10/01/2024
FDA Roundup: October 1, 2024
On Friday, the FDA updated At-Home OTC COVID-19 Diagnostic Tests to share that U.S. households are eligible to order four free COVID-19 tests at www.COVIDTests.gov.
Press Release / Public Statement
Medical Devices
09/24/2024
One Lot of Veklury (Remdesivir) for Injection 100 mg/vial by Gilead: Recall – Due to the Presence of a Glass Particle
Gilead Sciences is recalling of one lot of Veklury (Remdesivir) for Injection 100 mg/vial because Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.
Safety Information
Drugs
08/30/2024
FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants
Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.
Press Release / Public Statement
Biologics
08/22/2024
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
Press Release / Public Statement
Biologics
06/14/2024
FDA Roundup: June 14, 2024
On Thursday, the FDA updated its advice to manufacturers of COVID-19 vaccines (2024-2025 Formula). Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.
Press Release / Public Statement
Biologics
06/07/2024
FDA Roundup: June 7, 2024
Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.
Press Release / Public Statement
Biologics
06/05/2024
Vaccines and Related Biological Products Advisory Committee Meeting
On June 5, 2024, the committee will meet in open session to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines. View live webcast.
Event
Biologics
05/07/2024
FDA Roundup: May 7, 2024
Today, the FDA’s Center for Biologics Evaluation and Research (CBER) is announcing that the May 16, 2024, meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024.
Press Release / Public Statement
Biologics
04/05/2024
Ivermectin and COVID-19
There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.
Consumer Information
Drugs
04/05/2024
FDA Roundup: April 5, 2024
Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Press Release / Public Statement
Medical Devices
03/22/2024
FDA Roundup: March 22, 2024
Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
Press Release / Public Statement
Drugs
02/26/2024
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement
On May 16, 2024, the Committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines. Watch the webcast.
Event
Biologics
01/29/2024
FDA revises letter of authorization for the emergency use authorization for Paxlovid
The FDA revised the EUA for Paxlovid to continue to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid.
Press Release / Public Statement
Drugs
12/19/2023
Know Your Treatment Options for COVID-19 (updated)
Today you have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.
Consumer Information
Biologics
Drugs
11/21/2023
VAERS: A Critical Part of the National Vaccine Safety System
Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
FDA Voices: Leadership Perspectives
Biologics
11/09/2023
FDA Clears First COVID-19 Home Antigen Test
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
Press Release / Public Statement
Medical Devices
11/03/2023
FDA Roundup: November 3, 2023
On Wednesday, the FDA revised the EUA for Paxlovid to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid. The FDA has updated the frequently asked questions about Paxlovid during this transition period and encourages people to visit the HHS Paxlovid landing page for additional information.
Press Release / Public Statement
Drugs
11/01/2023
Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.
Safety Information
Biologics
10/03/2023
FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula.
Press Release / Public Statement
Biologics
9/11/2023
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
Today, the U.S. Food and Drug Administration took action on updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against the most serious outcomes, including hospitalization and death. Today’s actions relate to the updated mRNA vaccines for 2023-2024 made by Moderna and Pfizer-BioNTech.
Press Release / Public Statement
Biologics
7/14/2023
FDA Roundup: July 14, 2023
On Thursday, the FDA re-issued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).
Press Release / Public Statement
Inspections
6/16/2023
Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
The FDA posted information regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition.
Press Release / Public Statement
Biologics
6/15/2023
Vaccines and Related Biological Products Advisory Committee
The committee will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024. View webcast.
Event
Biologics
6/06/2023
FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process
FDA granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.
Press Release / Public Statement
Medical Devices
6/02/2023
FDA Roundup: June 2, 2023
On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine.
Press Release / Public Statement
Biologics
5/25/2023
FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
Press Release / Public Statement
Drugs
5/23/2023
FDA Roundup: May 23, 2023
On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics.
Press Release / Public Statement
Drugs
Biologics
Medical Devices
5/16/2023
FDA Roundup: May 16, 2023
Today, the FDA updated its new Rumor Control page to provide the facts and inform the public on how the growing spread of rumors, misinformation and disinformation about science, medicine and the FDA is putting patients, consumers and their families at risk.
Press Release / Public Statement
Drugs
Biologics
Medical Devices
5/12/2023
FDA Roundup: May 12, 2023
Today, the FDA updated information on medical device shortages on the FDA.gov website to reflect the end of the COVID-19 public health emergency (PHE), including providing answers to questions.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
Inspections
5/11/2023
Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.
FDA Voices: Leadership Perspectives
Research
Drugs
Biologics
Medical Devices
Inspections
5/11/2023
Preparing for and Responding to Future Public Health Security Threats
Hearing before the Health Subcommittee of the House Committee on Energy and Commerce; Commissioner Robert Califf, M.D. testifies for the FDA. View written testimony.
Event
Research
Drugs
Biologics
Medical Devices
5/9/2023
FDA Roundup Tuesday, May 9, 2023
On Friday, the FDA granted the first marketing authorizations for serology COVID-19 tests using a traditional premarket review process. The granting of these De Novo requests for Ortho-Clinical Diagnostics, Inc., is the latest example of the FDA’s ongoing commitment to maintain access to tests related to COVID-19.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
5/5/2023
FDA Roundup Friday, May 5, 2023
On Thursday, the FDA issued a safety communication to warn consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
5/2/2023
FDA Roundup Tuesday, May 2, 2023
Today, the FDA published a Conversations with Experts QA that focuses on the importance of the agency’s engagement with international organizations, discusses the objectives of the collaboration and how collectively it supports the FDA mission and strengthens the global food safety system.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/28/2023
FDA Roundup Friday, April 28, 2023
Today, the FDA issued a final guidance for industry titled Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products. The FDA intends for this guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products intended to help cigarette smokers stop smoking and for other related indications.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/21/2023
FDA Roundup Friday, April 21, 2023
On Thursday, the FDA authorized for marketing the Bateman Bottle Breast Implant Removal System (BIRS), a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. The FDA also announced it will reopen the comment period for the draft guidance entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/18/2023
FDA Roundup Tuesday, April 18, 2023
On Monday, the FDA granted marketing authorization to the NTX100 Tonic Motor Activation (NTX100 ToMAc) System to reduce the symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improve sleep quality among drug-resistant RLS patients.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/18/2023
FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
Press Release / Public Statement
Biologics
4/14/2023
FDA Roundup Friday, April 14, 2023
Today, the FDA issued an emergency use authorization (EUA) for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech, Inc.). The test can be used for people aged 14 years or older with a self-collected nasal swab sample and aged 2 years or older when an adult collects the nasal swab sample.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/11/2023
FDA Roundup Tuesday, April 11, 2023
On Monday, the FDA authorized for marketing the MISHA Knee System, an implant placed alongside the knee joint to help reduce the amount of load carried by part of the joint. Additionally, the FDA, in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, announced a virtual public meeting on May 10-11 titled, Considerations for Buprenorphine Initiation and Maintenance Care.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/7/2023
FDA Roundup Friday, April 7, 2023
Today, the FDA issued a recall notice about Philips Respironics Recall Certain Reworked DreamStations CPAP, BiPAP machines for the risk they may deliver inaccurate or insufficient therapy.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
4/3/2023
FDA Roundup Tuesday, April 4, 2023
Today, the FDA issued draft Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/31/2023
FDA Roundup Friday, March 31, 2023
Today, the FDA granted marketing authorization for the Masimo SafetyNet Opioid System, a monitoring device intended to recognize and respond by a series of escalating notifications when an individual may be experiencing Opioid Induced Respiratory Depression (OIRD) due to opioid use or overdose.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/28/2023
FDA Roundup Tuesday, March 28, 2023
Today, the FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market following a months-long infant formula shortage sparked by unsanitary conditions at one of the nation’s largest infant formula facilities.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/24/2023
FDA Roundup Friday, March 24, 2023
Today, the FDA finalized two guidances outlining the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/21/2023
FDA Roundup Tuesday, March 21, 2023
Today, the FDA completed its second pre-market consultation for a human food made from cultured animal cells. The agency also posted a warning letter issued to www.ivermectin4covid.com for offering drugs for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/17/2023
FDA Roundup Friday, March 17 2023
Today, the FDA issued an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/14/2023
FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age
The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine.
Press Release / Public Statement
Biologics
3/14/2023
FDA Roundup Tuesday, March 14, 2023
Yesterday, the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/10/2023
FDA Roundup Friday, March 10, 2023
Today, the FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/7/2023
FDA Roundup Tuesday, March 7, 2023
Today, the FDA issued a Letter to Health Care Providers about our expanded work to evaluate the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
3/3/2023
FDA Roundup Friday, March 3, 2023
The FDA and the Federal Trade Commission have been working to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Together, they have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/28/2023
FDA Roundup Tuesday, Feb 28, 2023
Today, the FDA is withdrawing the 2005 proposed rule, “Food Standards; General Principles and Food Standards Modernization,” in response to comments received in 2005 after publication of the proposed rule and in 2020 after the FDA reopened the comment period for the proposed rule.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/24/2023
FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
Press Release / Public Statement
Medical Devices
2/24/2023
FDA Roundup Friday, Feb 24 2023
On Thursday, the FDA issued a letter to health care providers informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/21/2023
FDA Roundup Tuesday, Feb 21, 2023
On Friday, the FDA published the FDA Voices: “Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In the first of a two-part series, Dr. Califf reflects on his one-year anniversary back at the agency and shares his vision for the future of the agency and its mission to protect and promote public health amid the enormous workload and societal forces that make the mission more challenging than in other times.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/17/2023
FDA Roundup Friday, Feb 17, 2023
On Wednesday, the FDA published the Medical Countermeasures Initiative (MCMi) Program Update report which showcases the FDA’s critical role each year in protecting the United States from chemical, biological, radiological and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/10/2023
FDA Roundup Friday, Feb 10 2023
Today, the FDA issued an emergency use authorization (EUA) for the Cepheid Xpert Mpox test for use in a point-of-care setting. This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/7/2023
FDA Roundup Tuesday, Feb 7 2023
On Monday, the FDA updated its step-by-step guide to include information about reporting your over-the-counter (OTC) at-home COVID-19 test result to MakeMyTestCount.org. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
2/3/2023
FDA Roundup Friday, Feb 3 2023
On Thursday, the FDA alerted consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. On Wednesday, the FDA revised the Letters of Authorization for two EUAs, Paxlovid and Lagevrio, to remove the requirement for positive test results to prescribe these products.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/31/2023
FDA Roundup Tuesday, Jan 31 2023
Today, Brian King, director of the Food and Drug Administration’s Center for Tobacco Products (CTP), published a perspective sharing information on key priority areas of the Center’s progress of tobacco regulation in 2022. The FDA and the Reagan-Udall Foundation for the FDA announced a virtual public meeting on March 8-9 titled, Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose, exploring the evolving context surrounding fatal overdoses and discussing epidemiological trends, drug supply changes, public health interventions to manage overdose, and drug development opportunities.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/26/2023
FDA announces Evusheld is not currently authorized for emergency use in the U.S.
The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
Press Release / Public Statement
Drugs
Biologics
1/24/2023
FDA Roundup Friday, Jan 24, 2023
On Monday, the FDA issued a final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry,” that provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds. The FDA also reopened the comment period for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services. Lastly, the agency cleared for marketing a mobile application intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons six years of age and older.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/20/2023
FDA Roundup Friday, Jan 20, 2023
Today, the FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. On Thursday, the FDA announced the availability of a draft guidance titled, “Mpox: Development of Drugs and Biological Products”.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/13/2023
FDA Roundup Friday, Jan 13, 2023
Today, the FDA released a fact sheet and constituent update to remind produce stakeholders of the upcoming end of the intended enforcement discretion period for the harvest and post-harvest agricultural water requirements in the Produce Safety Rule for covered produce other than sprouts. On Tuesday, the FDA published a Consumer Update and video reminding consumers that as of January 1, 2023, sesame is required to be labeled as an allergen on packaged foods, including dietary supplements.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/10/2023
FDA Roundup Tuesday, Jan 10, 2023
Today, the FDA’s “The Real Cost” Youth Cigarette Prevention Campaign announced two new ads focusing on the negative mental health effects of cigarette smoking and withdrawal and the frequency with which teens who smoke will continue into adulthood.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
1/06/2023
FDA Roundup Friday, Jan 6, 2023
The FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), the FDA does not anticipate that Evusheld will neutralize XBB.1.5, for more information click here. On Dec. 27, the FDA issued a warning letter to globalpharmacyplus.com for selling unapproved and misbranded drugs for use in treating or preventing COVID-19. Lastly, the FDA Grand Rounds lecture series will have a presentation on Jan. 12 from 12 to 1 pm ET, on the topic, “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars.”
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/30/2022
FDA Roundup: December 30, 2022
The FDA issued the 2022 edition of the FDA Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
12/23/2022
FDA Roundup December 23, 2022
This week, the FDA issued emergency use authorizations for two additional OTC at-home COVID-19 Tests and approved a new indication for Actemra (tocilizumab) injection for the treatment of hospitalized adult patients with COVID-19.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/20/2022
FDA Roundup December 20, 2022
Today, the FDA issued an emergency use authorization for the ImmuView COVID-19 Antigen Home Test and approved Zycosan for the control of clinical signs associated with osteoarthritis in horses.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/16/2022
FDA Roundup Dec. 16, 2022
The FDA is providing an easy step-by-step guide to help consumers decide when and how many times to test for COVID-19, what their test results mean and what they should do next.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/16/2022
FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19
On January 26, 2023, the FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.
Press Release / Public Statement
Biologics
12/13/2022
FDA Roundup Tuesday, Dec. 13, 2022
The FDA updated the device shortage list to remove medical gloves and will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/09/2022
FDA Roundup Friday, Dec 9, 2022
The FDA, in coordination with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, collaborated with the Conference of Food Protection to release food safety best practices for third-party delivery services.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
12/08/2022
FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age
The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.
Press Release / Public Statement
Biologics
12/06/2022
FDA Roundup Tuesday, Dec 6, 2022
The FDA issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/29/2022
FDA Roundup Tuesday, Nov. 29, 2022
Today, the FDA issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods.
Press Release / Public Statement
Research
Drugs
Biologics
Food & Beverages
Medical Devices
11/22/2022
FDA Roundup November 22, 2022
Today, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The Lucira COVID-19 and Flu Test is a single use molecular test intended for detection of both the SARS-CoV-2 virus and influenza (A or B) if a patient is suspected of respiratory viral infection consistent with COVID-19.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/18/2022
FDA Roundup November 18, 2022
Yesterday, the FDA provided an update on the Philips Respironics June 2021 recall. The FDA also published the FDA Voices: “FDA’s Cybersecurity Modernization Action Plan” and issued emergency use authorizations for the Hotgen COVID-19 Antigen Home Test and NIDS COVID-19 Antigen Home Test. The FDA also updated its Automated External Defibrillator web page yesterday. On Wednesday, the FDA published the FDA Voices: “Focusing on Prevention to Safeguard Infant Formula” and tips for buying medications online safely. The FDA also published a new report on Wednesday, titled Successes and Opportunities in Modeling & Simulation for FDA. On Wednesday, the FDA completed its first pre-market consultation for a human food made from cultured animal cells and also announced the availability of a draft amended Environmental Assessment (EA) for an approved application concerning Atlantic salmon with an intentionally altered genome (known as AquAdvantage Salmon, or AAS), and a subsequent virtual public meeting to obtain public input on the draft amended EA. Also on Wednesday, the FDA announced approving Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar. On Tuesday, in collaboration with FDA, MITRE updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/15/2022
FDA Roundup November 15, 2022
Today, the FDA issued an EUA to Roche Molecular Systems, Inc. for a molecular diagnostic test for monkeypox and released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. On Thursday, the FDA, in conjunction with CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey as well as published a consumer update advising individuals to learn about the risks and benefits of enrolling their children in clinical trials. On Nov. 8, the FDA issued an EUA for Kineret (anakinra) injection.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/08/2022
FDA Roundup November 8, 2022
Today, the FDA warned health care professionals to be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/04/2022
FDA Roundup November 4, 2022
On Thursday, the FDA issued a safety communication warning parents, caregivers, and health care providers not to use infant head shaping pillows intended to change an infant’s head shape and/or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows. These infant head shaping pillows are unapproved medical devices that may create an unsafe sleep environment. The safety communication provides important information about unapproved infant head shaping pillows, including:
Background on the potential risk of death or injury in infants.
Recommendations for parents, caregivers, and health care providers.
FDA actions to increase awareness of this safety concern.
Instructions for reporting problems to the FDA and the manufacturer.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
11/01/2022
FDA Roundup November 1, 2022
Today, the FDA issued a proposed rule to amend the color additive regulations to increase the fees for certification services.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
10/28/2022
FDA Roundup: October 28, 2022
Today, the FDA updated the list of Breakthrough Devices that have been authorized for marketing. The list includes 56 Breakthrough Devices that the FDA has authorized for marketing. Online metrics show the number of granted Breakthrough Device designations by fiscal year and by clinical panel, which totals 728 as of September 30, 2022.
Press Release / Public Statement
Research
Drugs
Biologics
Food & Beverages
Medical Devices
10/25/2022
FDA Roundup: October 25, 2022
Today, the FDA issued a Safety Communications warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the risks of injury, including electric shocks, skin burns, rashes or irritation. Yesterday, Whele LLC, announced a recall of over 500,000 Mighty Bliss electric heating pads that were distributed between July 2021 and July 2022.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
10/21/2022
FDA Roundup: October 21, 2022
This week the FDA announced two upcoming workshops with NIH to promote medical device innovation relating to development and monitoring devices for patients using opioids and risk prediction devices of opioid use and opioid use disorder; authorized the Novavax COVID-19 Vaccine, Adjuvanted; and issued several guidance’s across the agency.
Press Release / Public Statement
Research
Drugs
Biologics
Medical Devices
10/18/2022
FDA Roundup: October 18, 2022
Today, in addition to providing COVID-19 testing updates, the FDA issued an emergency use authorization (EUA) for the first over-the-counter molecular test authorized for use with saliva specimens and reminded consumers that the annual influenza, or flu, vaccine is the best way to prevent the flu for people ages 6 months and older.
Press Release / Public Statement
Research
Drugs
Biologics
10/14/2022
FDA Roundup: October 14, 2022
Today, in addition to providing COVID-19 testing updates, the FDA published two FDA Voices titled “FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing” and “FDA Releases New, Prevention Strategies to Enhance Food Safety”, published a reminder about how getting vaccinated in the fall can lower your chances of getting the flu, and announced an upcoming public meeting about the Animal Generic Drug User Fee Act (AGDUFA).
Press Release / Public Statement
Research
Drugs
Biologics
10/12/2022
FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
Press Release / Public Statement
Biologics
10/11/2022
FDA Roundup: October 11, 2022
Today, in addition to providing COVID-19 testing updates, the FDA announced the launch of the FDA’s Center for Devices and Radiological Health voluntary Total Product Life Cycle Advisory Program (TAP) Pilot as well as an independent study by the National Academies of Sciences, Engineering, and Medicine on the Role of Seafood Consumption in Child Growth and Development, which supports the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead and cadmium from foods.
Press Release / Public Statement
Research
Food & Beverages
Biologics
Medical Devices
10/07/2022
FDA Roundup: October 7, 2022
Today, the FDA issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.
Press Release / Public Statement
Research
Biologics
Medical Devices
10/04/2022
FDA Roundup: October 4, 2022
Today, the FDA posted a Constituent Update, highlighting that in September, the FDA and CDC signed a MOU to strengthen food safety in retail environments. The goal of the renewed partnership between the FDA and the CDC is to help reduce the occurrence of foodborne illness in retail and foodservice establishments.
Press Release / Public Statement
Medical Devices
Biologics
09/30/2022
FDA Roundup: September 30, 2022
On Tuesday, the FDA announced updates to its COVID-19 test policy to address public health testing needs during this phase of the COVID-19 public health emergency. Over the last two years more than 400 COVID-19 tests have been granted emergency use authorization and there are generally enough at-home tests, tests that can be used at the point-of-care such as health clinics, and laboratory-based tests to meet testing needs.
Press Release / Public Statement
Animal & Veterinary
Food & Beverages
Biologics
Drugs
09/27/2022
FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types
The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.
Press Release / Public Statement
Medical Devices
09/27/2022
FDA Roundup: September 27, 2022
Today, the FDA released its Activities to Enhance the Safety of Imported Produce, which provides an overview of the work underway to advance the safety of produce imported into the United States. This overview follows the 2019 release of the Strategy for the Safety of Imported Food (Import Strategy) that describes the agency’s comprehensive approach to enhancing the safety of food imported into the United States.
Press Release / Public Statement
Food & Beverages
Medical Devices
Biologics
09/23/2022
FDA Roundup: September 23, 2022
Today, the FDA published the FDA Voices: “FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death,” by Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research. The FDA is building on actions to help expand the availability and access to this life-saving medication, an effort that it is hoped will be embraced by harm reduction programs and manufacturers.
Press Release / Public Statement
Food & Beverages
Medical Devices
Biologics
Drugs
09/20/2022
FDA Roundup: September 20, 2022
Today, the FDA alerted medical device users about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System due to a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. A nearby person other than the user or care partner may be able to gain access to the pump while the pump is being paired with other system components and, if compromised, may cause the pump to deliver too much or too little insulin.
Press Release / Public Statement
Medical Devices
Biologics
Drugs
09/16/2022
FDA Roundup: September 16, 2022
Today, the FDA announced that it is taking steps to help increase the availability of novel treatments for rare diseases and conditions in dogs and cats and launched ORA News and Stories, a new, public-facing platform on FDA.gov from the Office of Regulatory Affairs as well as warned consumers about social media trends encouraging people to misuse nonprescription medications and provided COVID-19 testing updates.
Press Release / Public Statement
Animal & Veterinary
Food & Beverages
Medical Devices
Biologics
Drugs
09/13/2022
FDA Roundup: September 13, 2022
Today, the FDA reissued the letter of authorization for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis and also issued a draft guidance that provides recommendations on risk-based computer software assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system as well as provided COVID-19 testing updates.
Press Release / Public Statement
Biologics
Medical Devices
09/09/2022
FDA Roundup: September 9, 2022
Today, the FDA posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox.
Press Release / Public Statement
Food & Beverages
Medical Devices
Biologics
Drugs
09/06/2022
FDA Roundup: September 6, 2022
Today, the FDA published the 2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research.
Press Release / Public Statement
Medical Devices
Biologics
Drugs
09/02/2022
FDA Roundup: September 2, 2022
On Thursday, the FDA published the FDA Voices: “Using A Whole-Of-Governments Approach to Combating Illicit Health Products,” by Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the FDA’s Europe Office.
Press Release / Public Statement
Medical Devices
Biologics
Drugs
08/31/2022
FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose
The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Press Release / Public Statement
Biologics
08/30/2022
FDA Roundup: August 30, 2022
Today, the FDA published the FDA Voices: “FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death,” by Robert M. Califf, M.D., Commissioner of Food and Drugs.
Press Release / Public Statement
Animal & Veterinary
Medical Devices
Biologics
Drugs
08/26/2022
FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply
This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators.
Press Release / Public Statement
Medical Devices
08/26/2022
FDA Roundup: August 26, 2022
Today, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time.
Press Release / Public Statement
Food & Beverages
Biologics
Drugs
Tobacco
08/23/2022
FDA Roundup: August 23, 2022
Today, the FDA’s Office of Global Policy and Strategy posted an article about the FDA’s fruitful partnership with the Inter-American Institute for Cooperation in Agriculture. Additionally, on October 11, the FDA and the Duke-Margolis Center for Health Policy will hold a virtual public workshop titled, “Challenges and Opportunities for REMS Integration, Innovation, and Modernization.”
Press Release / Public Statement
Food & Beverages
Biologics
Drugs
08/19/2022
FDA Roundup: August 19, 2022
Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.
Press Release / Public Statement
Medical Devices
Biologics
08/18/2022
Report: FDA’s Work to Combat the COVID-19 Pandemic
Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.
Consumer Information
Food & Beverages
Animal & Veterinary
Medical Devices
Biologics
Drugs
Inspections
Warning Letters
Guidance Documents
Research
08/16/2022
FDA Roundup: August 16, 2022
Today, the FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. The agency also warned the public about certain spray sunscreens that have been recalled because of benzene contamination and launched a new external webpage to highlight the Operation Lascar Initiative.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
08/12/2022
FDA Roundup: August 12, 2022
Today, the FDA posted a safety communication to provide information to blood establishments regarding monkeypox virus and blood donations.
Press Release / Public Statement
Biologics
Drugs
08/09/2022
FDA Roundup: August 9, 2022
Today, the FDA’s Office of Global Policy and Strategy published “How a European Data Law is Impacting FDA,” which looks at how the European Union’s General Data Protection Regulation may be impacting the FDA’s public health activities.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
08/05/2022
FDA Roundup: August 5, 2022
On Wednesday, the FDA published the FDA Voices: “FDA Recognizes National Immunization Awareness Month,” by Robert M. Califf, M.D., FDA Commissioner. The FDA plays a key role in immunization by evaluating vaccines for safety and effectiveness before they are made available to the public.
Press Release / Public Statement
Biologics
Drugs
Animal & Veterinary
Medical Devices
Tobacco
08/02/2022
FDA Roundup: August 2, 2022
The FDA announced the approval of the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses.
Press Release / Public Statement
Food & Beverages
Animal & Veterinary
07/29/2022
FDA Roundup: July 29, 2022
On Tuesday, the FDA updated the FAQs on Testing for SARS-CoV-2 to note that no tests remain on the commercial manufacturer serology test notification list described in the FDA’s Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an Emergency Use Authorization or should no longer be distributed, marketed, or offered.
Press Release / Public Statement
Food & Beverages
Animal & Veterinary
Medical Devices
07/26/2022
FDA Roundup: July 26, 2022
The FDA released new updates detailing the agency’s Cyclospora prevention and research efforts. Cyclospora cayetanensis (C. cayetanensis) is a parasite that causes the foodborne intestinal illness cyclosporiasis. People can become infected with cyclosporiasis by ingesting food or water that’s contaminated with C. cayetanensis. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea, and fatigue.
Press Release / Public Statement
Drugs
Medical Devices
Food & Beverages
07/22/2022
FDA Roundup: July 22, 2022
The FDA today published the “Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe” guidance which provides information and recommendations for industry on potential courses of action for an abbreviated new drug application applicant after the issuance of a complete response letter and the actions the FDA can take if the applicant fails to respond to a CRL.
Press Release / Public Statement
Drugs
Medical Devices
Food & Beverages
07/19/2022
FDA Roundup: July 19, 2022
The FDA today updated the device shortage list and the device discontinuance list on the web page for Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
Medical Devices
07/15/2022
FDA Roundup: July 15, 2022
The FDA today announced the agency’s Total Diet Study Report: Fiscal Years 2018-2010 Elements Data. The agency also issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus; announced the availability of educational resources for parents and caregivers with questions about using imported infant formula; provided updates on the FDA’s continued implementation of a new law to regulate non-tobacco nicotine products; and authorized additional over-the-counter at-home COVID-19 antigen tests.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
Medical Devices
Tobacco
07/13/2022
FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
Press Release / Public Statement
Biologics
07/08/2022
FDA Roundup: July 8, 2022
The FDA announced approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age. The agency also finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Additionally, the agency will continue hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24 from 12:05 p.m. – 1 p.m. ET.
Press Release / Public Statement
Biologics
Animal & Veterinary
Medical Devices
07/06/2022
Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations
The FDA revised the EUA for Paxlovid to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
Press Release / Public Statement
Drugs
07/05/2022
FDA Roundup: July 5, 2022
The FDA announced registration opened for the 2022 Public Meeting of National Antimicrobial Resistance Monitoring System. The agency also issued warning letters, jointly with the Federal Trade Commission to four companies for selling unapproved kratom products and to one company for selling essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. Additionally the agency announced its July Grand Rounds lecture series topic, “One Health at FDA: From Concept to Application.”
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
07/01/2022
FDA Roundup: July 1, 2022
Today, the FDA announced a request for nominations for consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future.
Press Release / Public Statement
Animal & Veterinary
Biologics
Drugs
Medical Devices
06/30/2022
Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.
Press Release / Public Statement
Biologics
06/28/2022
FDA Roundup: June 28, 2022
The FDA announces the authorization of an extension to the shelf-life of the refrigerated AstraZeneca monoclonal antibody, Evusheld, which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Consumers concerned about COVID-19 should consult with their health care provider.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
Food & Beverages
06/24/2022
FDA Roundup: June 24, 2022
Today, the FDA announced its recognition of JANAAC as an Accreditation Body Under FSMA- Accredited Third Party Certification Program for a period of five years.
Press Release / Public Statement
Biologics
Medical Devices
Food & Beverages
06/17/2022
FDA Roundup: June 17, 2022
The FDA sends Congress its Report on Drug Shortages for Calendar Year 2021 and announces the publication of three International Test Method Standards in Nanotechnology by the American Society for Testing and Materials (ASTM) International.
Press Release / Public Statement
Biologics
06/17/2022
FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Press Release / Public Statement
Biologics
06/16/2022
An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Commissioner Robert Califf, M.D. testifies for the FDA. View written testimony.
Event
Biologics
Drugs
Medical Devices
Food & Beverages
06/14/2022
FDA Roundup: June 14, 2022
On Friday, the FDA issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system.
Press Release / Public Statement
Medical Devices
06/10/2022
FDA Roundup June 10, 2022
Today, the FDA authorized the marketing of two new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. On Thursday, the FDA warned about the potential dangers of products for treating moles, seborrheic keratoses, or skin tags. The agency is advising consumers to avoid these products because of their potentially harmful side effects and serious risks.
Press Release / Public Statement
Biologics
Tobacco
06/07/2022
FDA Roundup June 7, 2022
On Friday, the FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19.
Press Release / Public Statement
Biologics
Medical Devices
06/03/2022
FDA Roundup June 3, 2022
Wednesday, the FDA authorized changes to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (supplied in multiple dose vials with purple caps), to include additional updated expiration dates in the Fact Sheet. A copy of the granting letter and updated Fact Sheet are posted on the FDA’s website.
Press Release / Public Statement
Biologics
Medical Devices
05/31/2022
FDA Roundup May 31, 2022
The FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) are pleased to invite you to their free, virtual Regulatory Education for Industry (REdI) Annual Conference 2022 which will be held June 6 through June 10.
Press Release / Public Statement
Biologics
Medical Devices
05/27/2022
FDA Roundup May 27, 2022
On May 20, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.
Press Release / Public Statement
Biologics
Medical Devices
05/24/2022
FDA Roundup May 24, 2022
On May 23, the FDA announced the availability of one final guidance and two draft guidances for blood establishments, as well as the availability of a report drafted by the Regan-Udall Foundation summarizing key findings from a series of targeted conversations with stakeholders about the feasibility of establishing a voluntary public-private partnership to collect and analyze antimicrobial use data from food-producing animals. On May 17, the FDA authorized marketing of BONESUPPORT AB Cerament G, a bone void filler (bone graft substitute) with the antibiotic gentamicin added, that is the first device-drug combination product of its kind.
Press Release / Public Statement
Biologics
Medical Devices
05/20/2022
FDA Roundup May 20, 2022
On May 17, the FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies.
Press Release / Public Statement
Biologics
Medical Devices
05/17/2022
FDA Roundup May 17, 2022
On May 15, the FDA issued an Emergency Use Authorization (EUA) for the Laboratory Corporation of America (Labcorp) Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test.
Press Release / Public Statement
Biologics
Medical Devices
05/17/2022
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.
Press Release / Public Statement
Biologics
05/16/2022
FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
Today, the FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. The test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, commonly known as the flu, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2, the virus that causes COVID-19.
Press Release / Public Statement
Medical Devices
05/10/2022
FDA Roundup: May 10, 2022
Today, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Press Release / Public Statement
Biologics
Medical Devices
05/06/2022
FDA Roundup: May 6, 2022
On Thursday, through the American Rescue Plan Act of 2021, Congress provided temporary funding for the FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022.
Press Release / Public Statement
Biologics
Food & Beverages
Medical Devices
05/05/2022
Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
Press Release / Public Statement
Biologics
05/03/2022
FDA Roundup: May 3, 2022
On Friday, the FDA warned there are counterfeit versions of the following at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States.
Press Release / Public Statement
Biologics
Food & Beverages
Medical Devices
04/29/2022
FDA Roundup: April 29, 2022
On Thursday, the FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test.
Press Release / Public Statement
Biologics
Food & Beverages
Medical Devices
04/29/2022
Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
Today, the FDA is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
Press Release / Public Statement
Biologics
04/26/2022
FDA Roundup: April 26, 2022
The FDA announced the May and June dates for the Virtual Town Hall Series for Test Developers on Coronavirus (COVID-19). The new time for the events will be from 12:05 p.m. – 1 p.m. ET
Press Release / Public Statement
Tobacco
Medical Devices
04/22/2022
FDA Roundup: April 22, 2022
Tuesday, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to Kleenhanz, LLC for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
Press Release / Public Statement
Drugs
Medical Devices
04/19/2022
FDA Roundup: April 19, 2022
Today, the FDA issued its final rule titled “Beverages: Bottled Water”. This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L). The proposed rule published in April 2019.
Press Release / Public Statement
Animal & Veterinary
Drugs
Food & Beverages
Medical Devices
Tobacco
04/15/2022
FDA Roundup: April 15, 2022
On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDA’s continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
Tobacco
04/14/2022
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
Today, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
Press Release / Public Statement
Medical Devices
04/12/2022
FDA Roundup: April 12, 2022
As part of the FDA’s effort to protect consumers, on April 5, the agency issued a warning letter to CofixRx, LLC for selling an unapproved product with misleading COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
Press Release / Public Statement
Drugs
Medical Devices
04/08/2022
FDA Roundup: April 8, 2022
On April 7, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
04/05/2022
FDA Roundup: April 5, 2022
Today, the FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
04/01/2022
FDA Roundup: April 1, 2022
The FDA published two FDA voices – “Give Your Community a Boost: Combatting Misinformation Through Communication and Research” and “FDA’s Technology and Data Modernization in Action in 2022.” The FDA also published findings from a facility inspection of Abbott Nutrition in Sturgis, Michigan, revised the guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19, denied two the request in two citizen petitions, published the FDA voices announced the extension of a public comment period, approved a new animal drug, updated a list of which regions in which the drug Sotrovimab is not authorized, approved a medical device to treat defects or legions that can occur in cartilage covering bones in the knee joint, authorized marketing of a medical device for measuring the brain temperature of neonates (infants less than four weeks old) and updated a fact sheet and FAQ regarding dosing information of Evusheld.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
Medical Devices
03/29/2022
FDA Roundup: March 29, 2022
Today, the FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
03/29/2022
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.
Press Release / Public Statement
Biologics
03/25/2022
FDA Roundup: March 25, 2022
Today, the FDA announced the COVID-19 treatment sotrovimab is no longer authorized for use at this time in the U.S. Health and Human Services (HHS) regions 1 and 2 due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
03/22/2022
FDA Roundup: March 22, 2022
On March 21, the FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
03/21/2022
Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters
On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.
Press Release / Public Statement
Biologics
03/18/2022
FDA Roundup: March 18, 2022
The FDA issues warning letters against companies selling misbranded and unapproved drugs, and updates frequently asked questions to the COVID-19 Test FAQs.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
03/15/2022
FDA Roundup: March 15, 2022
On March 10, as part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Soda Pharm for selling unapproved products with fraudulent COVID-19 claims.
Press Release / Public Statement
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/11/2022
FDA Roundup: March 11, 2022
As part of the FDA’s effort to protect consumers, on March 7, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.
Press Release / Public Statement
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/08/2022
FDA Roundup: March 8, 2022
Today, the FDA announced the signing of a domestic mutual reliance partnership agreement with the Minnesota Department of Agriculture, a consent decree of permanent injunction was signed by a judge requiring Salud Natural Entrepreneur, Inc. of Illinois not to engage in any distribution operations until it completes corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), and announced a low-risk determination for the marketing of products from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns.
Press Release / Public Statement
Animal & Veterinary
Drugs
Food & Beverages
Medical Devices
03/04/2022
FDA Roundup: March 4, 2022
FDA posted an FDA Voices piece on speeding therapies for rare diseases and announced, with NASA, NIH and HHS, the award of eight contracts to extend longevity of complex in vitro (human) models.
Press Release / Public Statement
Drugs
Medical Devices
03/01/2022
FDA Roundup: March 1, 2022
Today, the FDA issued a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging. The test has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.
Press Release / Public Statement
Animal & Veterinary
Food & Beverages
Medical Devices
02/25/2022
FDA Roundup: February 25, 2022
On Feb. 24, the FDA issued an update on our continuing efforts to understand and reduce exposure to PFAS from foods. The FDA made available new PFAS test results from our most recent survey of the general food supply that showed three samples—tilapia, cod, and shrimp, had detectable levels of at least one type of PFAS. Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the samples tested indicate a need to avoid any particular food. The FDA also posted on the Authorized Uses of PFAS in Food Contact Applications webpage, the first annual updates provided to the FDA from the three manufacturers that committed to the voluntary market phase-out of certain short-chain PFAS used in food packaging.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
02/22/2022
FDA Roundup: February 22, 2022
Today, the FDA posted a new resource, At-Home COVID-19 Diagnostic Tests, that provides a list of all FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests. Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19. At-home OTC COVID-19 diagnostic tests play a key role in the fight against COVID-19.
Press Release / Public Statement
Drugs
Medical Devices
02/18/2022
FDA Roundup: February 18, 2022
Today, the FDA that it has found an additional four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The agency also warned consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. Additionally, the FDA published a new batch of product-specific guidances to provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval.
Press Release / Public Statement
Biologics
Food & Beverages
Drugs
Medical Devices
02/15/2022
FDA Roundup: February 15, 2022
Today, the FDA released a request for public comments about antimicrobial use in companion animals and the potential impact of this use on antimicrobial resistance in both animals and people. The agency also published the FDA Voices, “Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021.” Additionally, the FDA provided updates on interim results from two postmarket studies on Essure. Finally, the agency issued a warning letter to the operator of one website, www.pharmacy2home.com, for offering for sale in the U.S. unapproved drugs for multiple diseases, including COVID-19.
Press Release / Public Statement
Animal & Veterinary
Drugs
Medical Devices
02/11/2022
FDA Roundup: February 11, 2022
On Feb. 7, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Also, as of today, 421 tests and sample collection devices for the virus that causes COVID-19 are authorized by the FDA under emergency use authorizations (EUAs).
Press Release / Public Statement
Drugs
Medical Devices
02/11/2022
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.
Press Release / Public Statement
Drugs
Biologics
02/11/2022
FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
The FDA has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
Press Release / Public Statement
Biologics
02/08/2022
FDA Roundup: February 8, 2022
The FDA issued a guidance for industry and investigators to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19. The agency also warned health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets.
Press Release / Public Statement
Drugs
Medical Devices
02/04/2022
FDA Roundup: February 4, 2022
The FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country. The FDA also issued a draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure. Additionally, the FDA announced its 2022-2025 strategic priorities for the Center for Devices and Radiological Health, a proposed rule to improve the security of the drug supply chain as well as a new website showcasing the Center for Veterinary Medicine’s innovative research to protect human and animal health.
Press Release / Public Statement
Drugs
Animal & Veterinary
Medical Devices
02/01/2022
Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
Press Release / Public Statement
Biologics
02/01/2022
FDA Roundup: February 1, 2022
The FDA issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The FDA also published the 2021 Center for Devices and Radiological Health (CDRH) annual report, announced an upcoming workshop related to multi-component biomarkers and released a list of guidance topics that are a priority for the FDA Foods Program as well as a video that provides an overview of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
01/31/2022
FDA Takes Key Action By Approving Second COVID-19 Vaccine
The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
Press Release / Public Statement
Biologics
01/28/2022
FDA Roundup: January 28, 2022
The FDA added four bulk drug substances to list of substances that may be used in compounding by outsourcing facilities. FDA also posted an article discussing the agency’s commitment toward advancing two proposed tobacco product standards and published several guidances on generic drug application submissions, labeling and review.
Press Release / Public Statement
Drugs
Food & Beverages
Medical Devices
Tobacco
01/25/2022
FDA Roundup: January 25, 2022
The FDA authorized another over-the-counter COVID-19 antigen test and also provided updates to its web pages on In Vitro Diagnostics EUAs for Molecular and Antigen Diagnostic Tests for SARS-CoV-2.
Press Release / Public Statement
Animal & Veterinary
Drugs
Food & Beverages
Medical Devices
01/24/2022
Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
The FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.
Press Release / Public Statement
Drugs
01/21/2022
FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19
The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.
Press Release / Public Statement
Drugs
01/21/2022
FDA Roundup: January 21, 2022
The FDA extended the previously announced temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.
Press Release / Public Statement
Animal & Veterinary
Drugs
Medical Devices
01/18/2022
FDA Roundup: January 18, 2022
The FDA published the CDRH Health of Women Program Strategic Plan, which outlines the program’s priorities to protect and promote the health of women.
Press Release / Public Statement
Food & Beverages
Medical Devices
01/14/2022
FDA Roundup: January 14, 2022
The FDA published an FDA Voices entitled, Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues, which highlights the wide variety of safe and effective new drug therapies approved in 2021 despite challenges brought on by the ongoing COVID-19 pandemic.
Press Release / Public Statement
Animal & Veterinary
Cosmetics
Drugs
Food & Beverages
Medical Devices
01/13/2022
FDA 2021 Year in Review – Working for You
This year end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments. The report also highlights ways the FDA strengthened maternal and infant health, modernized food safety, and protected young people from the harmful effects of tobacco.
Consumer Information
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
Research
Tobacco
01/11/2022
FDA Roundup: January 11, 2022
The FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension).
Press Release / Public Statement
Drugs
Medical Devices
01/11/2022
Addressing New Variants: A Federal Perspective on the COVID-19 Response
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testifies for the FDA. View written testimony.
Event
Biologics
Drugs
Food & Beverages
Medical Devices
01/07/2022
FDA Roundup: January 7, 2022
The FDA published an interactive public data dashboard for viewing historical data from the Reportable Food Registry, issued an outbreak advisory regarding two salad blends, announced two virtual public meetings on a recently released proposed rule, and added organ preservation solutions to the device shortage list.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
Medical Devices
01/07/2022
Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months
Today, the FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
Press Release / Public Statement
Biologics
01/04/2022
FDA Roundup: January 4, 2022
The FDA published a webpage describing the FDA has developed the capacity to sequence SARS-CoV-2 RNA from wastewater samples, approved a generic drug application for Albuterol Sulfate Inhalation Solution, implemented temporary changes to agency inspection activities, issued warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims, announced three lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export, updated the SARS-CoV-2 viral mutations webpage, and authorized two additional OTC antigen tests.
Press Release / Public Statement
Drugs
Biologics
Medical Devices
01/03/2022
FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.
Press Release / Public Statement
Biologics
12/28/2021
Coronavirus (COVID-19) Update
The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests.
COVID-19 Update
Drugs
Medical Devices
12/23/2021
Coronavirus (COVID-19) Update
This week, the FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients; and released a joint statement with ASPR on the circulating SARS-CoV-2 viral variants, including Omicron.
COVID-19 Update
Drugs
Medical Devices
12/23/2021
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
The FDA issued an emergency use authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in certain adults.
Press Release / Public Statement
Drugs
12/22/2021
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
Today, the FDA issued an emergency use authorization for the first oral antiviral for treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds).
Press Release / Public Statement
Drugs
12/21/2021
Coronavirus (COVID-19) Update
The FDA and its global partners will use machine learning approaches to enhance the understanding of nonclinical model responses to SARS-CoV-2.
COVID-19 Update
Medical Devices
12/17/2021
Coronavirus (COVID-19) Update
The FDA approved a manufacturing change for Comirnaty to include a formulation that uses a different buffer; and an abbreviated new drug application for increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines (a class of neurotransmitters).
COVID-19 Update
Biologics
Drugs
Medical Devices
12/14/2021
Coronavirus (COVID-19) Update
The Janssen COVID-19 fact sheets have been updated to include contraindications for people with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.
COVID-19 Update
Biologics
Medical Devices
12/10/2021
Coronavirus (COVID-19) Update
The FDA updates information about the Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including the impact of the SARS-CoV-2 omicron variant on test performance.
COVID-19 Update
Medical Devices
12/09/2021
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds
Today, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
Press Release / Public Statement
Biologics
12/08/2021
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
Today, the FDA issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
Press Release / Public Statement
Drugs
12/07/2021
Coronavirus (COVID-19) Update
The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, including FDA recommendations for clinical laboratory staff and health care providers. Additionally, the agency also added the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test to another list of impacted tests.
COVID-19 Update
Medical Devices
12/03/2021
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
FDA revised the EUA of bamlanivimab and etesevimab, administered together, to treat mild to moderate COVID-19 in all younger pediatric patients, including newborns. The drug combination is also now authorized for post-exposure prevention of COVID-19 in all pediatric patients, including newborns.
Press Release / Public Statement
Drugs
11/30/2021
Coronavirus (COVID-19) Update
The FDA issues a statement regarding its work with federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant and announces a new project to expand the FDA-ARGOS database.
COVID-19 Update
Medical Devices
11/30/2021
Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters
FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.
Press Release / Public Statement
Biologics
Medical Devices
11/30/2021
Antimicrobial Drugs Advisory Committee Meeting
The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. View webcast.
Event
Drugs
11/23/2021
Coronavirus (COVID-19) Update
The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests; and approved an abbreviated new drug application to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.
COVID-19 Update
Drugs
Medical Devices
11/19/2021
FDA Expands Eligibility for COVID-19 Vaccine Boosters
The FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
Press Release / Public Statement
Biologics
11/16/2021
Coronavirus (COVID-19) Update
The FDA takes several actions to increase access to accurate and reliable COVID-19 tests.
COVID-19 Update
Medical Devices
11/15/2021
Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests
Today, the FDA is taking several important actions to support ongoing nationwide COVID-19 testing efforts.
Press Release / Public Statement
Medical Devices
11/12/2021
Coronavirus (COVID-19) Update
The FDA posted an updated Molecular and Antigen Home Use Test Template intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The template is intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA.
COVID-19 Update
Medical Devices
11/05/2021
Coronavirus (COVID-19) Update
The FDA has issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes.
COVID-19 Update
Biologics
Medical Devices
11/04/2021
Next Steps: The Road Ahead for the COVID-19 Response
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testifies for the FDA. View written testimony.
Event
Biologics
Drugs
Food & Beverages
Medical Devices
11/02/2021
Coronavirus (COVID-19) Update
The FDA recently revised several extramural research contracts in the Medical Countermeasures Initiative (MCMi) Regulatory Science Program to expand efforts supporting COVID-19 medical countermeasure development.
COVID-19 Update
Biologics
Medical Devices
10/29/2021
Coronavirus (COVID-19) Update
The FDA discussed the agency’s actions to expand the use of a single booster dose for COVID-19 vaccines in eligible populations. In addition, the FDA authorized the 11th over-the-counter (OTC) COVID-19 test and is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new.
COVID-19 Update
Biologics
Medical Devices
10/29/2021
FDA Authorizes COVID-19 Vaccine in Children 5 through 11
The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
Press Release / Public Statement
Biologics
10/26/2021
Coronavirus (COVID-19) Update
The FDA authorized the 10th over-the-counter (OTC) COVID-19 test, reissued the emergency use authorization (EUA) for another OTC COVID-19 test, and updated the EUA templates for test developers seeking an EUA for OTC tests.
COVID-19 Update
Medical Devices
10/26/2021
Vaccines and Related Biological Products Advisory Committee Meeting
The committee will discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. View livestream.
Event
Biologics
10/22/2021
Coronavirus (COVID-19) Update
Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.
COVID-19 Update
Drugs
Medical Devices
10/20/2021
FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. Listen to the media call.
Press Release / Public Statement
Biologics
10/19/2021
Coronavirus (COVID-19) Update
On Oct. 12, the FDA approved an abbreviated new drug application for propofol injectable emulsion, single patient-use vials. This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database. Side effects of propofol emulsion injection include hypotension (low blood pressure), bradycardia (low heart rate), and apnea (temporary stopping of breathing).
COVID-19 Update
Drugs
Medical Devices
10/15/2021
Coronavirus (COVID-19) Update
On Oct. 12, the FDA posted information about an assessment of the Emergency Use Authorization (EUA) process that the FDA’s Center for Devices and Radiological Health (CDRH) implemented to help authorize COVID-19 tests. The Center for Food Safety and Applied Nutrition published a Constituent Update intended for food and agriculture workers/industry encouraging vaccination against influenza and COVID-19.
COVID-19 Update
Medical Devices
Food & Beverages
10/14/2021 – 10/15/2021
Vaccines and Related Biological Products Advisory Committee Meeting
The committee will discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine and the Janssen Biotech Inc. COVID-19 vaccine for the administration of an additional dose, or “booster” dose, following completion of the primary series, to individuals 18 years of age and older. View October 14 livestream. View October 15 livestream.
Event
Biologics
10/14/2021
FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
The U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) on November 30 to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.
Press Release / Public Statement
Drugs
10/12/2021
Coronavirus (COVID-19) Update
Today, the FDA announced that it intends to withdraw, effective Dec. 31, 2021, guidance documents originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency.
COVID-19 Update
Drugs
Medical Devices
10/08/2021
Coronavirus (COVID-19) Update
On Tuesday October 5, the FDA issued a safety communication to alert test users, caregivers, health care personnel and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue.
COVID-19 Update
Medical Devices
10/05/2021
Coronavirus (COVID-19) Update
On Sept. 28, the FDA will issue a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims. The agency recommends that consumers who have concerns about COVID-19 should consult with their health care provider.
COVID-19 Update
Medical Devices
10/04/2021
Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers
FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 test, which adds to the growing list of tests that can be used at home without a prescription.
Press Release / Public Statement
Medical Devices
10/01/2021
Coronavirus (COVID-19) Update
The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDA’s Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.
COVID-19 Update
Biologics
Drugs
Medical Devices
10/01/2021
FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children
The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
Press Release / Public Statement
Biologics
09/24/2021
Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose
Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the Pfizer-BioNTech COVID-19 Vaccine booster dose.
Podcast / Video
Biologics
09/22/2021
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.
Press Release / Public Statement
Biologics
09/20/2021
Podcast: COVID-19 Vaccine Boosters and COVID-19 Vaccines for Kids
Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the COVID-19 vaccine (“boosters”) and COVID-19 vaccines for kids under 12
Podcast / Video
Biologics
09/17/2021
Coronavirus (COVID-19) Update
The FDA took the following actions in the agency’s ongoing response to the COVID-19 pandemic: issued a Letter to Health Care Providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits; revised the Emegency Use Authorization (EUA) for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19; issued a revised guidance to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency; and authorized the use, under the EUA for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility.
COVID-19 Update
Biologics
Drugs
Medical Devices
09/17/2021
Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. View livestream.
Event
Biologics
09/16/2021
FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
The FDA revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Post-exposure prophylaxis with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19.
Press Release / Public Statement
Biologics
Drugs
09/10/2021
Coronavirus (COVID-19) Update
The FDA approved an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, authorized the use–under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine–of one additional batch of vaccine drug substance manufactured at the Emergent facility, and issued a revised guidance which provides general recommendations to prospective generic drug applicants in the form of questions and answers that have been addressed during the COVID-19 public health emergency. The FDA also posted a statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children”.
COVID-19 Update
Biologics
Drugs
Medical Devices
09/10/2021
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.
Press Release / Public Statement
Biologics
09/08/2021
Virtual Town Hall Series – COVID-19 Test Development and Validation
FDA will host a virtual Town Hall on 9/8/2021 from 12:15 to 1:15 ET to help answer technical questions about the development and validation of tests for SARS-CoV-2. Participants may ask questions during the call or submit questions by noon on 9/8/2021 to CDRHWebinars@fda.hhs.gov.
Event
Medical Devices
09/07/2021
Coronavirus (COVID-19) Update
FDA issued a warning letter to a company for not complying with federal laws and regulations during the clinical investigation of an investigational drug to mitigate and treat COVID-19.
COVID-19 Update
Medical Devices
09/01/2021
FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.
Press Release / Public Statement
Biologics
08/31/2021
Coronavirus (COVID-19) Update
The FDA makes changes to the authorized use of the monoclonal antibodies bamlanivimab and etesevimab, and issues a letter to veterinarians and retailers about the dangerous misuse of animal ivermectin to prevent or treat COVID-19 in people.
COVID-19 Update
Medical Devices
08/30/2021
Help Stop Misuse of Animal Ivermectin to Prevent or Treat COVID-19 in Humans
Today the FDA issued a letter to veterinarians and retailers to help stop the misuse of animal ivermectin to prevent or treat COVID-19 in humans. Poison control centers across the United States are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin.
Safety Information
Animal & Veterinary
08/27/2021
Resumption in Use and Distribution of Bamlanivimab/Etesevimab in Certain States
Today the FDA reissued the Letter of Authorization to allow for the emergency use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Health care providers may refer to the fact sheet and frequently asked questions for more information.
Press Release / Public Statement
Drugs, Biologics
08/27/2021
Coronavirus (COVID-19) Update
The FDA issued a letter to health care providers alerting health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. and the agency issued a warning letter to Invisi Smart Technologies for offering for sale adulterated and misbranded Invisi Smart Masks.
COVID-19 Update
Medical Devices
08/24/2021
Coronavirus (COVID-19) Update
The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.
COVID-19 Update
Biologics
Medical Devices
08/23/2021
FDA Approves First COVID-19 Vaccine
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Press Release / Public Statement
Biologics
08/20/2021
Coronavirus (COVID-19) Update
The FDA issued a warning letter regarding sale of unapproved products with unproven COVID-19 claims and held a stakeholder call in recognition of National Immunization Awareness Month to discuss vaccines for younger children and adolescents in preparation for the school year.
COVID-19 Update
Medical Devices
08/18/2021
Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots
Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.
Press Release / Public Statement
Biologics
08/13/2021
Coronavirus (COVID-19) Update
A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDA’s vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.
COVID-19 Update
Biologics
08/12/2021
FDA Authorizes Additional Vaccine Dose for Immunocompromised People
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Press Release / Public Statement
Biologics
08/06/2021
Coronavirus (COVID-19) Update
Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use.
COVID-19 Update
Medical Devices
08/03/2021
Coronavirus (COVID-19) Update
In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, including preliminary reports of Guillain-Barré Syndrome following Janssen (Johnson & Johnson) COVID-19 vaccination. Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers. The call can be found on the FDA’s YouTube page.
COVID-19 Update
Biologics
Medical Devices
07/30/2021
Coronavirus (COVID-19) Update
The FDA revised the Emergency Use Authorization for REGEN-COV as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals who are at high risk for progression to severe COVID-19, including hospitalization or death.
COVID-19 Update
Medical Devices
07/23/2021
Coronavirus (COVID-19) Update
On Thursday, July 22 the FDA issued an Emergency Use Authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing.
COVID-19 Update
Medical Devices
07/20/2021
Coronavirus (COVID-19) Update
Today, Acting FDA Commissioner Janet Woodcock, M.D. testified before the U.S. Senate Committee on Health, Education, Labor and Pensions in a hearing titled, The Path Forward: A Federal Perspective on the COVID-19 Response.
COVID-19 Update
Biologics
Medical Devices
07/20/2021
The Path Forward: A Federal Perspective on the COVID-19 Response
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testifies for the FDA. Read written testimony.
Event
Biologics
Drugs
Food & Beverages
Medical Devices
07/16/2021
Coronavirus (COVID-19) Update
The FDA formally accepts Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
COVID-19 Update
Biologics
Medical Devices
07/13/2021
Coronavirus (COVID-19) Update
The FDA announces revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine.
COVID-19 Update
Biologics
Medical Devices
07/13/2021
Webinar: Revocation of EUAs for Non-NIOSH-Approved Respirators and Decontamination Systems
From 12:00 to 1:00 p.m. ET on Tuesday, July 13, 2021, the FDA will host a webinar to share information and answer questions about revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.
Event
Medical Devices
07/09/2021
Coronavirus (COVID-19) Update
The FDA issued a report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response, an EUA to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test as well as warning letters to 12 firms for offering for sale in the U.S. adulterated and misbranded tests, face masks, respirators and surgical masks, some of which are intended for use in the mitigation, prevention, treatment, diagnosis or cure of COVID-19 in people.
COVID-19 Update
Biologics
Medical Devices
07/08/2021
Joint CDC and FDA Statement on Vaccine Boosters
Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.
Press Release / Public Statement
Biologics
07/06/2021
Coronavirus (COVID-19) Update
The FDA holds a stakeholder call with Vaccinate Your Family and pediatric and healthcare groups.
COVID-19 Update
Biologics
Medical Devices
07/02/2021
Coronavirus (COVID-19) Update
The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. Additionally, the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.
COVID-19 Update
Biologics
Medical Devices
06/30/2021
FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
FDA announced it is revoking EUAs of all non-NIOSH-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.
Press Release / Public Statement
Medical Devices
06/29/2021
Coronavirus (COVID-19) Update
The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020, which includes a section on the agency’s drug shortage efforts in response to COVID-19. The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act.
COVID-19 Update
Drugs
06/25/2021
Coronavirus (COVID-19) Update
The FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination; and reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic.
COVID-19 Update
Biologics
Drugs
Medical Devices
Warning Letters
06/24/2021
FDA Authorizes Drug for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Press Release / Public Statement
Biologics
Drugs
06/22/2021
Coronavirus (COVID-19) Update
The FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger; and issued a warning letter to a company selling an unapproved product with fraudulent COVID-19 claims.
COVID-19 Update
Drugs
Warning Letters
06/15/2021
Coronavirus (COVID-19) Update
The FDA posts updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers and issues an updated FDA COVID-19 Response At-A-Glance Summary.
COVID-19 Update
Biologics
Medical Devices
06/11/2021
Coronavirus (COVID-19) Update
FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. FDA also added sodium citrate tubes used in blood specimen collection to the device shortage list.
COVID-19 Update
Medical Devices
06/11/2021
FDA Takes Steps to Increase Availability of COVID-19 Vaccine
Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
Press Release / Public Statement
Biologics
06/10/2021
Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss, in general, data needed to support authorization and/or licensure of COVID-19 vaccines for use in pediatric populations. View livestream
Event
Biologics
06/08/2021
Coronavirus (COVID-19) Update
The White House, HHS and FDA release a series of policy recommendations to address vulnerabilities in U.S. pharmaceutical supply chains, and FDA issues warning letters for sale of unapproved products with unproven COVID-19 claims.
COVID-19 Update
Medical Devices
06/04/2021
Coronavirus (COVID-19) Update
On June 1, the FDA approved an abbreviated new drug application for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation. Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients four years of age and older.
COVID-19 Update
Drugs
Medical Devices
06/01/2021
Coronavirus (COVID-19) Update
The FDA issued a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests.
COVID-19 Update
Medical Devices
05/28/2021
Coronavirus (COVID-19) Update
FDA releases the Medical Countermeasures Initiative (MCMi) Program Update report which showcases FDA’s work each year to prepare for all types of public health emergencies, including COVID-19.
COVID-19 Update
Drugs
Medical Devices
05/26/2021
FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
Today, the FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Press Release / Public Statement
Drugs
05/25/2021
Coronavirus (COVID-19) Update
The FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.
COVID-19 Update
Biologics
Medical Devices
05/21/2021
Coronavirus (COVID-19) Update
The FDA updated the definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease.
COVID-19 Update
Drugs
Medical Devices
Warning Letters
05/19/2021
FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available
FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
Press Release / Public Statement
Biologics
05/19/2021
FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination
FDA issued a safety communication to advise against using SARS-CoV-2 antibody test results to evaluate immunity after COVID-19 vaccination.
Press Release / Public Statement
Medical Devices
05/18/2021
Coronavirus (COVID-19) Update
The FDA provided summary information about the status of CytoDyn, Inc.’s development program for the monoclonal antibody investigational drug, leronlimab, for the treatment of COVID-19.
COVID-19 Update
Medical Devices
05/14/2021
Coronavirus (COVID-19) Update
The FDA issued a warning letter to Crown Wellness, Inc. for, among other things, selling an unapproved product with COVID-19 claims.
COVID-19 Update
Medical Devices
05/11/2021
Coronavirus (COVID-19) Update
The FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include 12 – 15 year olds and issued an updated FDA COVID-19 Response At-A-Glance Summary.
COVID-19 Update
Biologics
Warning Letters
05/11/2021
An Update from Federal Officials on Efforts to Combat COVID-19
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. testifies for the FDA. View written testimony.
Event
Biologics
Drugs
Food & Beverages
Medical Devices
05/10/2021
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. View press briefing.
Press Release / Public Statement
Biologics
05/10/2021
FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines
The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.
Press Release / Public Statement
Biologics
05/07/2021
Coronavirus (COVID-19) Update
The agency issued a warning letter to Disinfect & Shield for selling an unapproved product with fraudulent COVID-19 claims.
COVID-19 Update
Medical Devices
05/05/2021
Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
FDA issued a new report outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations.
Press Release / Public Statement
Biologics
Drugs
Food & Beverages
Medical Devices
05/04/2021
Coronavirus (COVID-19) Update
The FDA updated the CDER’s work to meet user fee goals webpage to include data from Fiscal Year 2021 Quarter 2.
COVID-19 Update
Drugs
Medical Devices
04/30/2021
Coronavirus (COVID-19) Update
The FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System and updated the EUA Authorized Serology Test Performance page on the FDA’s website.
COVID-19 Update
Drugs
Medical Devices
04/27/2021
Coronavirus (COVID-19) Update
The FDA lifted the recommended pause on the use of Janssen (Johnson & Johnson) COVID-19 Vaccine following a thorough safety review; and issued warning letters to companies selling unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Biologics
Drugs
Medical Devices
04/23/2021
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.
Press Release / Public Statement
Biologics
04/23/2021
Coronavirus (COVID-19) Update
The FDA completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine and cited a number of observations concerning whether the facility’s processes met the agency’s requirements and standards. Additionally, the FDA’s Center for Food Safety and Applied Nutrition updated its COVID-19 Vaccination & Food and Agriculture Sector webpage to include the HHS COVID-19 Vaccination Toolkit for agriculture workers.
COVID-19 Update
Medical Devices
04/21/2021
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
The FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness.
Press Release / Public Statement
Biologics
04/20/2021
Coronavirus (COVID-19) Update
The FDA took steps to further facilitate the authorization of tests for pooling specimens from asymptomatic individuals in serial testing programs, and issued a pooling and serial testing amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA) for testing individual samples.
COVID-19 Update
Medical Devices
04/20/2021
FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs
Today, the FDA took steps to further facilitate the authorization of molecular tests for screening asymptomatic individuals using pooled anterior nasal respiratory specimens in serial testing programs.
Press Release / Public Statement
Medical Devices
04/16/2021
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
Press Release / Public Statement
Drugs
04/16/2021
Coronavirus (COVID-19) Update
The FDA issues a statement regarding the Janssen COVID-19 vaccine, issues a warning letter and updates a frequently asked question about the Moderna COVID-19 vaccine.
COVID-19 Update
Biologics
Drugs
Medical Devices
04/13/2021
Coronavirus (COVID-19) Update
The FDA publishes a new FDA Voices on addressing COVID-19 health disparities among racial and ethnic minority communities.
COVID-19 Update
Biologics
Drugs
Medical Devices
04/13/2021
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
Press Release / Public Statement
Biologics
04/12/2021
Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities
As FDA celebrates National Minority Health Month, we’re working to address concerns about vaccines among diverse communities, and to protect and promote the health of diverse populations by focusing our efforts on strategies that address health disparities.
FDA Voices: Leadership Perspectives
Biologics
04/09/2021
Coronavirus (COVID-19) Update
The FDA recommends health care personnel and facilities transition from the use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Medical Devices
Warning Letters
04/06/2021
Coronavirus (COVID-19) Update
The FDA issues COVID-19 related Emergency Use Authorization and implements a new guidance.
COVID-19 Update
Drugs
Medical Devices
04/06/2021
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
The FDA today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
Press Release / Public Statement
Medical Devices
04/02/2021
Coronavirus (COVID-19) Update
The FDA has taken swift action to get more tests for screening asymptomatic individuals on the market by authorizing several COVID-19 tests for over-the-counter (OTC) use without a prescription when used for serial screening; posted a new web page SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests for clinical laboratory staff and health care providers; posted five additional translations to a COVID-19 consumer update; and issued a warning letter jointly with the Federal Trade Commission to Natural Adventure, LLC for selling unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Drugs
Medical Devices
04/02/2021
FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative
This FDA In Brief provides an update on the PREPP initiative
Press Release / Public Statement
Biologics
Drugs
Medical Devices
04/01/2021
Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available
Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
Press Release / Public Statement
Biologics
03/31/2021
Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development
Following recent FDA actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.
Press Release / Public Statement
Medical Devices
03/30/2021
Coronavirus (COVID-19) Update
The FDA has updated its FDA COVID-19 Response At-A-Glance Summary and has approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
COVID-19 Update
Drugs
Medical Devices
03/26/2021
Coronavirus (COVID-19) Update
The FDA issues an emergency use authorization (EUA) to a company for the SARS-CoV-2 NGS Assay and provides a consumer update on common questions about COVID-19 vaccines.
COVID-19 Update
Biologics
Medical Devices
3/24/2021
Learn More About COVID-19 Vaccines From the FDA
Answers from the FDA to common questions about COVID-19 vaccines.
Consumer Information
Biologics
03/23/2021
Coronavirus (COVID-19) Update
The FDA issues a warning letter to a company selling unapproved products with fraudulent COVID-19 claims and provides a consumer update on steps to help slow the spread of the coronavirus disease.
COVID-19 Update
Drugs
Medical Devices
03/19/2021
Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
Today, the FDA issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
Press Release / Public Statement
Medical Devices
03/19/2021
Coronavirus (COVID-19) Update
FDA authorizes the first SARS-CoV-2 diagnostic test for marketing beyond the public health emergency and posts a web page with screening information for newly established testing programs.
COVID-19 Update
Biologics
Drugs
Medical Devices
03/18/2021
FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization
FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19.
Press Release / Public Statement
Biologics
Drugs
03/18/2021
FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
The agency’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.
FDA Voices: Leadership Perspectives
Inspections
03/18/2021
Senate Health, Education, Labor, and Pensions Committee Hearing
FDA leadership will participate in the hearing titled “Examining Our COVID-19 Response: An Update from Federal Officials.”
View livestream and written testimony
Event
Imports
Inspection
Recalls
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/17/2021
Webinar: Therapeutics for Use in COVID-19
Acting FDA commissioner, Janet Woodcock, M.D. participated in a webinar for physicians to discuss the state of therapeutic clinical trials worldwide.
Podcast / Video
Drugs
Research
03/17/2021
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
Press Release / Public Statement
Medical Devices
03/17/2021
House Subcommittee Hearing on COVID-19 Vaccinations
FDA leadership will participate in the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce hearing entitled, “Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations.”
View livestream and written testimony
Event
Biologics
03/16/2021
Coronavirus (COVID-19) Update
FDA launches the COVID-19 EUA FDA Adverse Events Reporting System Public Dashboard and issues a warning letter for sale of unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Biologics
Drugs
Medical Devices
03/16/2021
Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs.
Press Release / Public Statement
Medical Devices
03/12/2021
Coronavirus (COVID-19) Update
FDA issues a warning letter, a Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff and Health Care Providers and an Emergency Use Authorization (EUA).
COVID-19 Update
Drugs
Medical Devices
03/11/2021
Know Your Treatment Options for COVID-19
Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration (FDA) has approved one drug treatment for COVID-19 and authorized others for emergency use.
Consumer Information
Biologics
Drugs
03/09/2021
Coronavirus (COVID-19) Update
FDA authorizes first molecular non-prescription, at-home test.
COVID-19 Update
Drugs
Medical Devices
03/05/2021
Health Fraud & COVID-19: What You Need to Know
FDA’s Office of Minority Health and Health Equity discusses the agency’s efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19.
Podcast / Video
Inspections
03/05/2021
Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
Press Release / Public Statement
Medical Devices
03/05/2021
Coronavirus (COVID-19) Update
The FDA provides update that improper use of thermal imaging systems may provide inaccurate temperature readings and issues several warning letters.
COVID-19 Update
Biologics
Drugs
Medical Devices
03/05/2021
Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils.
Press Release / Public Statement
Medical Devices
03/04/2021
FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras”—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors.
Press Release / Public Statement
Medical Devices
03/03/2021
COVID-19 Alert: Beware of Misleading Registration Certificates
In response to an increase in the use of misleading FDA registration certificates during the COVID-19 pandemic, the FDA has developed a new web resource for consumers: Are there “FDA Registered” or “FDA Certified” Medical Devices?
Consumer Information
Medical Devices
Warning Letters
03/02/2021
National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country.
FDA Voices: Leadership Perspectives
Biologics
Warning Letters
03/02/2021
Coronavirus (COVID-19) Update
The FDA issues Voices on protecting consumers against COVID-19 vaccine scams and issues a warning letter to a company selling unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Biologics
Drugs
Medical Devices
03/01/2021
Stakeholder Call: COVID-19 Testing Update
Acting FDA Commissioner, Janet Woodcock, M.D., and Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, provide updates on recent work and host a question and answer session on #COVID-19 testing.
Podcast / Video
Medical Devices
03/01/2021
Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
Today, the FDA issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.
Press Release / Public Statement
Medical Devices
02/27/2021
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Press Release / Public Statement
Biologics
02/26/2021
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
Press Release / Public Statement
Biologics
02/26/2021
Coronavirus (COVID-19) Update
Today, the FDA added new devices to the device discontinuance list, including sterilization products and oxygen conservers.
COVID-19 Update
Biologics
Drugs
Medical Devices
02/26/2021
Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. View livestream
Event
Biologics
02/25/2021
Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
Today, the FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.
Press Release / Public Statement
Biologics
02/25/2021
Health Equity and Covid-19: What Minority Communities Need To Know
Join the FDA’s Office of Minority Health and Health Equity for a conversation about health equity and COVID-19 with Dr. Peter Marks and RADM Richardae Araojo. Learn about the latest COVID-19 updates, including information about vaccines and the FDA’s approval process.
Event
Biologics
02/23/2021
Coronavirus (COVID-19) Update
FDA issued guidances for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2.
COVID-19 Update
Biologics
Drugs
Medical Devices
02/22/2021
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
Today, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
02/19/2021
Coronavirus (COVID-19) Update
FDA issued a warning letter to Dr. Paul’s Lab for selling an unapproved product with fraudulent COVID-19 claims.
COVID-19 Update
Drugs
Medical Devices
02/18/2021
COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
The USDA and FDA underscore epidemiologic and scientific information indicating no transmission of COVID-19 Through Food or Food Packaging
Press Release / Public Statement
Food & Beverages
02/16/2021
Coronavirus (COVID-19) Update
FDA issued a warning letter to Evolved Ayurvedic Discoveries, Inc./BioCBDPlus for selling unapproved products, including unapproved products with fraudulent COVID-19 claims.
COVID-19 Update
Drugs
Medical Devices
02/12/2021
Coronavirus (COVID-19) Update
FDA issued an emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients and also revised its guidance, Investigational COVID-19 Convalescent Plasma.
COVID-19 Update
Biologics
Drugs
Medical Devices
02/09/2021
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Today, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.
Press Release / Public Statement
Drugs
02/09/2021
Coronavirus (COVID-19) Update
FDA issued a Letter to Health Care Providers on using ventilator splitters during the COVID-19 pandemic to provide up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters.
COVID-19 Update
Medical Devices
02/05/2021
Coronavirus (COVID-19) Update
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee; alerted health care professionals and compounders of potential risks associated with compounding remdesivir drug products; revised the Letter of Authorization for COVID-19 convalescent plasma; and issued a statement that FDA continues important work to support medical product development to address new virus variants.
COVID-19 Update
Biologics
Drugs
Medical Devices
02/04/2021
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
Press Release / Public Statement
Biologics
02/04/2021
FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
The FDA is issuing a revision of the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma as a result of our evaluation of the most recent information available.
Press Release / Public Statement
Biologics
02/04/2021
Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
01/29/2021
Coronavirus (COVID-19) Update
The FDA placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert; issued warning letters jointly with the Federal Trade Commission to two companies selling unapproved products with fraudulent COVID-19 claims; and updated the COVID-19 frequently asked questions (FAQ).
COVID-19 Update
Biologics
Drugs
Medical Devices
01/26/2021
Coronavirus (COVID-19) Update
The FDA has updated its COVID-19 Response At-A-Glance Summary; and posted a CDER Conversation with Katie Gray, Pharm.D., acting director of CDER’s Office of Prescription Drug Promotion (OPDP) discussing OPDP’s COVID-19 response.
COVID-19 Update
Drugs
Medical Devices
01/26/2021
Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment.
Press Release / Public Statement
Drugs
01/22/2021
Coronavirus (COVID-19) Update
The FDA has investigated a case of fraud that led to an arrest and the filing of a criminal complaint by the U.S. Department of Justice; reissued the Emergency Use Authorization for decontamination systems for compatible N95 respirators; and added two new devices to the device discontinuance list.
COVID-19 Update
Drugs
Medical Devices
01/19/2021
Coronavirus (COVID-19) Update
The FDA issued a new guidance to help protect consumers from methanol poisoning, created a new collaboration with the National Institute of Standards and Technology to help strengthen the nation’s public health infrastructure, updated its guidance on convalescent plasma donation, and provided updates for blood donation centers on blood donation during the COVID-19 pandemic.
COVID-19 Update
Biologics
Drugs
Medical Devices
01/19/2021
FDA Insight: Pandemic Recovery and Preparedness Plan
Listen to this FDA podcast featuring the FDA Commissioner and Deputy Commissioner for Medical and Scientific Affairs, for a discussion on FDA’s Pandemic Recovery and Preparedness Plan.
Podcast / Video
Biologics
Food & Beverages
Drugs
Medical Devices
01/15/2021
Coronavirus (COVID-19) Update
The FDA issued three new guidances in its ongoing response to the COVID-19 pandemic.
COVID-19 Update
Biologics
Drugs
Medical Devices
01/13/2021
Pandemic Response, Pandemic Preparation
This report reflects highlights of the agency’s response, accomplishments and activities and describes a broad set of potential prospective actions that the agency could consider going forward.
FDA Voices: Leadership Perspectives
Biologics
Drugs
Medical Devices
01/08/2021
Coronavirus (COVID-19) Update
The FDA posts a new webpage regarding Moderna COVID-19 vaccine frequently asked questions and issues letter to clinical laboratory staff and health care providers.
COVID-19 Update
Biologics
Medical Devices
Warning Letters
01/08/2021
FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
FDA is alerting labs and health care providers that it is monitoring the impact of viral mutations, including the B.1.1.7 variant, on SARS-CoV-2 molecular tests.
Press Release / Public Statement
Medical Devices
01/05/2021
Coronavirus (COVID-19) Update
The FDA issues a warning letter and posts a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
COVID-19 Update
Drugs
Medical Devices
01/05/2021
FDA Insight: Compounded Drugs
Gail Bormel from the Office of Compliance in FDA’s Center for Drug Evaluation and Research joins Dr. Shah for a discussion on drug compounding and its contribution to fighting COVID-19.
Podcast / Video
Drugs
01/04/2021
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Following the Authorized Dosing Schedules for COVID-19 Vaccines
Press Release / Public Statement
Biologics
01/04/2021
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
The FDA is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.
Safety Information
Medical Devices
12/30/2020
Coronavirus (COVID-19) Update
The FDA publishes a new communications toolkit web hub and a hand sanitizer toolkit, posts a year-end FDA Voices blog and an infographic on tests and collection kits, issues two health frauds WLs, and approves two ANDAs.
COVID-19 Update
Drugs
Medical Devices
12/28/2020
Coronavirus (COVID-19) Update
The FDA posts an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, updated the Device Shortage List, and provides a testing update.
COVID-19 Update
Biologics
Medical Devices
12/28/2020
Video Discussion: COVID-19 Vaccines
In this 30-minute video discussion, FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks talk with WebMD about what we know, what we don’t know, and what we might learn in the future about COVID-19 vaccines.
Podcast / Video
Biologics
12/22/2020
Coronavirus (COVID-19) Update
The FDA posts translations of the Moderna COVID-19 Vaccine fact sheet in multiple languages, issues new ANDAs, and provides a testing update.
COVID-19 Update
Biologics
Drugs
Medical Devices
12/21/2020
Coronavirus (COVID-19) Update
The FDA posts translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet in multiple languages, issues a new guidance, and provides a testing update.
COVID-19 Update
Biologics
Medical Devices
12/18/2020
FDA Media Briefing
FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020.
Event
Biologics
12/18/2020
FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Press Release / Public Statement
Biologics
12/18/2020
Tell Me More About Vaccine Safety
Learn more about COVID-19 vaccine safety monitoring from FDA Commissioner Dr. Stephen Hahn
Podcast / Video
Biologics
12/17/2020
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
Press Release / Public Statement
Biologics
12/17/2020
Coronavirus (COVID-19) Update
The FDA holds a VRBPAC meeting, posts a new vaccine Q&A webpage, issues a WL, and provides a testing update.
COVID-19 Update
Biologics
Drugs
Medical Devices
12/17/2020
Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna Inc. COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. View livestream recording
Event
Biologics
12/16/2020
Coronavirus (COVID-19) Update
The FDA posts materials for the 12/17 VRBPAC, issues two EUAs for at-home diagnostic tests, and provides a testing update.
COVID-19 Update
Biologics
Medical Devices
12/16/2020
Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
Today, the FDA issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test to allow individuals to perform the test at home with a prescription.
Press Release / Public Statement
Medical Devices
12/15/2020
Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.
Press Release / Public Statement
Medical Devices
12/14/2020
Coronavirus Vaccine FDA Update
Peter W. Marks, M.D., Ph.D. and Stephen M. Hahn, M.D. return to JAMA’s Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the data, the weekend’s EUA designation (Pfizer/BioNTech), and the process for future full licensure and postmarketing safety surveillance.
Podcast / Video
Biologics
12/14/2020
Coronavirus (COVID-19) Update
The FDA releases its Pfizer vaccine review memorandum, issues health fraud warning letters, posts a new video on hand sanitizer use, and more.
COVID-19 Update
Biologics
Drugs
Medical Devices
12/12/2020
Virtual Press Conference: First COVID-19 Vaccine
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube, Facebook and Twitter accounts on December 12, 2020, at 9:00 AM ET.
Event
Biologics
12/11/2020
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Press Release / Public Statement
Biologics
12/11/2020
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
Press Release / Public Statement
Biologics
12/10/2020
Coronavirus (COVID-19) Update
The FDA holds a VRBPAC meeting, grants an EUA for the first direct-to-home COVID test, issues a health fraud warning letter, and updates testing numbers.
COVID-19 Update
Biologics
Drugs
Medical Devices
12/10/2020
Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. View livestream
Event
Biologics
12/10/2020
Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, is meeting to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.
Press Release / Public Statement
Biologics
12/09/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System
Today, the FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.
Press Release / Public Statement
Medical Devices
12/08/2020
Coronavirus (COVID-19) Update
The FDA adds background material to web for upcoming VRBPAC meeting, approves new ANDA, issues safety message warning consumers not to wear face masks with metal parts during an MRI, authorizes first at-home diagnostic test to detect both COVID-19 and influenza A and B (flu), and provides a testing update.
COVID-19 Update
Biologics
Drugs
Medical Devices
12/08/2020
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
The FDA continues this series of webinars on topics including respirators, surgical masks, protective barrier enclosures, gowns, and other apparel used by health care personnel during the COVID-19 pandemic.
Event
Medical Devices
12/07/2020
Remarks by Dr. Hahn to the FDA-CMS Summit
Event
Biologics
Drugs
Medical Devices
12/04/2020
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples
The FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
Press Release / Public Statement
Medical Devices
12/04/2020
Coronavirus (COVID-19) Update
The FDA issues new guidance and an EUA, updates another guidance, and launches an immunology app-a-thon.
COVID-19 Update
Medical Devices
12/04/2020
Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine
Event
Biologics
12/03/2020
Coronavirus (COVID-19) Update
The FDA issues a health fraud warning letters and updates the reference panel comparative date online.
COVID-19 Update
Drugs
Medical Devices
12/02/2020
Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
12/01/2020
Coronavirus (COVID-19) Update
The FDA amends the convalescent plasma EUA, issues health fraud warning letters, revises guidance, and updates testing numbers.
COVID-19 Update
Biologics
Drugs
Medical Devices
11/30/2020
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
Press Release / Public Statement
Biologics
11/25/2020
Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
Today, the FDA issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency.
Press Release / Public Statement
Medical Devices
11/24/2020
Thank You, Food and Agriculture Workers! | Español
To the millions of food and agriculture workers across America at Thanksgiving, the FDA is Giving Thanks for you!
Podcast / Video
Food & Beverages
11/24/2020
Coronavirus (COVID-19) Update
The FDA publishes new web resources, provides a testing update, approves an ANDA, and posts a “Thank You” video to our food and agriculture workers.
COVID-19 Update
Drugs
Medical Devices
11/23/2020
Coronavirus (COVID-19) Update
The FDA issues an ANDA, an EUA, and posts a new infographic on the potential EUA pathway for vaccines.
COVID-19 Update
Biologics
Drugs
Medical Devices
11/21/2020
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.
Press Release / Public Statement
Drugs
11/20/2020
Coronavirus (COVID-19) Update
The FDA issues an EUA, two warning letters, and more.
COVID-19 Update
Biologics
Drugs
Medical Devices
11/20/2020
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
Press Release / Public Statement
Biologics
11/20/2020
The FDA published new information about the vaccine development and review process:
Consumer Information
Biologics
11/19/2020
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
Today, the FDA issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Press Release / Public Statement
Drugs
11/19/2020
FDA and Vaccinate Your Family Talk COVID With Minority Community Leaders
FDA leaders participate in a virtual meeting with racial and ethnic minority community members about FDA’s COVID-19 vaccine work.
Event
Biologics
11/17/2020
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
Today, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.
Press Release / Public Statement
Medical Devices
11/17/2020
Coronavirus (COVID-19) Update
The FDA published information on EUA transparency, an update to SARS-CoV-2 FAQs, and a podcast on PPE.
COVID-19 Update
Medical Devices
11/17/2020
FDA Insight: Personal Protective Equipment and COVID-19
Dr. Suzanne Schwartz, director of FDA’s Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health, discusses personal protective equipment and its critical role in helping to reduce the spread of COVID-19.
Podcast / Video
Medical Devices
11/17/2020
COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
Statement reaffirming FDA’s commitment to transparency around the EUA process and updates on FDA’s plan to provide more information about decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Press Release / Public Statement
Biologics
Drugs
11/17/2020
Dr. Hahn’s Remarks to the Meeting of the Regulatory Affairs Professionals Society (RAPS)
Event
Biologics
Drugs
Medical Devices
11/16/2020
Coronavirus (COVID-19) Update
The FDA updates guidance on investigational COVID-19 convalescent plasma, extending the period of enforcement discretion through the end of February 2021, and publishes a new COVID-19 diagnostic testing webpage for health care providers and others.
COVID-19 Update
Biologics
Medical Devices
11/16/2020
A Closer Look at COVID-19 Diagnostic Testing
This overview may be of interest to health care providers, test purchasers, and public health staff who want to know more about different types of tests. A printable PDF is also available.
Consumer Information
Medical Devices
11/13/2020
Coronavirus (COVID-19) Update
The FDA takes further action against company distributing a fraudulent product claiming to prevent or treat COVID-19.
COVID-19 Update
Drugs
Medical Devices
11/12/2020
Coronavirus (COVID-19) Update
The FDA issues new Consumer Update offering tips on how to spot fraudulent flu products and updates treatment numbers on its CTAP dashboard.
COVID-19 Update
Medical Devices
11/10/2020
Coronavirus (COVID-19) Update
The FDA to host a virtual “Grand Rounds” presentation on the agency’s research to evaluate the ability of facial coverings to reduce the spread of infection and more.
COVID-19 Update
Medical Devices
11/10/2020
FDA Insight Podcast: Hand Hygiene During COVID-19
Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic.
Podcast / Video
Drugs
Recalls
11/09/2020
Coronavirus (COVID-19) Update
The FDA issues an EUA for an investigational monoclonal antibody therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients, a final guidance on designing and executing clinical trials that include people with diverse characteristics, a testing update, and more.
COVID-19 Update
Biologics
Drugs
Medical Devices
11/09/2020
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Press Release / Public Statement
Drugs
11/09/2020
Remarks by FDA Commissioner Dr. Stephen Hahn to the GRx+Biosims 2020 Virtual Conference
Event
Biologics
Drugs
11/09/2020
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
Statement by FDA Commissioner Dr. Stephen Hahn about a final guidance Issued today that provides the agency’s current thinking on steps to enhance diversity in clinical trials of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly.
Press Release / Public Statement
Biologics
Drugs
11/06/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection
Today, the FDA authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.
Press Release / Public Statement
Medical Devices
11/04/2020
Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
11/03/2020
Coronavirus (COVID-19) Update
The FDA issues two health fraud warning letters, an alert that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2, and more.
COVID-19 Update
Drugs
Medical Devices
11/01/2020
Lessons Learned From COVID
Remarks by Dr. Stephen Hahn for the Global Pharmaceutical Manufacturing Leadership Forum
Event
Biologics
Drugs
Medical Devices
10/30/2020
Coronavirus (COVID-19) Update
The FDA issues a new Consumer Update.
COVID-19 Update
Medical Devices
10/28/2020
Coronavirus (COVID-19) Update
The FDA updates an immediately in effect guidance, approves two generic muscle relaxation drugs, and issues warning letters.
COVID-19 Update
Drugs
Medical Devices
10/28/2020
Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
10/27/2020
I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.
USA Today Opinion: FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks
Press Release / Public Statement
Biologics
10/27/2020
Get Your Flu Vaccine
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, discusses this year’s flu season and the importance of getting vaccinated as we continue the fight against the COVID-19 pandemic.
Podcast / Video
Biologics
10/27/2020
Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
During this webinar, the FDA will share information about surgical mask 510(k)s and representatives from the FDA and from the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) will be available to answer your questions.
Event
Medical Devices
10/26/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA updates the Antigen Template for Test Developers.
Daily Roundup
Medical Devices
10/26/2020
FDA Presentation: American Public Health Association’s 2020 Virtual Annual Meeting
Bruce Ross, director of the FDA’s Office of Global Operations, on the topic “Department of Health and Human Services’ Global Health Workforce – On the Front Lines of Health Diplomacy During the Time of COVID-19.”
Event
Biologics
Drugs
Medical Devices
10/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA approves first drug to treat COVID-19 and issues an updated FDA COVID-19 Response At-A-Glance Summary.
Daily Roundup
Biologics
Drugs
Medical Devices
10/22/2020
FDA Commissioner Talks to AARP About COVID-19 Vaccines
Dr. Stephen Hahn explains the FDA’s role in ensuring safety, effectiveness of COVID-19 vaccines.
Consumer Information
Drugs
10/22/2020
FDA Approves First Treatment for COVID-19
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
Press Release / Public Statement
Drugs
10/22/2020
Vaccines and Related Biological Products Advisory Committee
The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast
Event
Biologics
10/21/2020
Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
10/20/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA publishes new content on the “FDA Insight” podcast, in “FDA Voices”, and issues a Consumer Update.
Daily Roundup
Biologics
Drugs
Medical Devices
10/20/2020
The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines
This week, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.
FDA Voices: Leadership Perspectives
Biologics
10/20/2020
Advisory Committee on COVID-19 Vaccines
Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
Podcast / Video
Biologics
10/19/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA issues a joint warning letter with the Federal Trade Commission to prevent the sale of unapproved products with fraudulent COVID-19 claims.
Daily Roundup
Drugs
Medical Devices
Warning Letters
10/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA re-issues Emergency Use Authorization for certain filtering facepiece respirators.
Daily Roundup
Medical Devices
10/15/2020
FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
The FDA reissued the EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).
Press Release / Public Statement
Medical Devices
10/14/2020
Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
10/13/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA issues and implements new guidance regarding molecular influenza and RSV tests.
Daily Roundup
Guidance Documents
Medical Devices
10/13/2020
Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
FDA and representatives from the Occupational Safety and Health Administration (OSHA) answered questions about protective barrier enclosures.
Event
Medical Devices
10/09/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA and the Federal Trade Commission issue warning letters for selling fraudulent COVID-19-related products.
Daily Roundup
Drugs
Warning Letters
10/08/2020
The Review Process for Vaccines to Prevent COVID-19: A Discussion
FDA Commissioner Dr. Steven Hahn discussed the COVID-19 vaccine review process with the Center for Infectious Disease Research and Policy and others.
Podcast / Video
Biologics
10/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA updates dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage.
Daily Roundup
Drugs
10/08/2020
Interview: FDA Commissioner on COVID-19 Vaccines and Other Medical Countermeasures
FDA Commissioner Dr. Steven Hahn spoke about the COVID-19 vaccine development process and other medical countermeasures for COVID-19.
Podcast / Video
Biologics
10/07/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA issues letter to healthcare providers regarding SARS-CoV-2 testing, and a warning letter for failure to comply with regulatory reporting requirements.
Daily Roundup
Medical Devices
Warning Letters
10/07/2020
FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators
The FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System.
Press Release / Public Statement
Medical Devices
Warning Letters
10/06/2020
Tell Me More About Vaccines
Learn more about how vaccines are developed from U.S. Department of Health and Human Services leaders.
Podcast / Video
Biologics
10/06/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA launches new COVID-19 vaccine webpage and issues guidance with recommendations for vaccine sponsors.
Daily Roundup
Biologics
Guidance Documents
10/06/2020
FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
Recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.
Press Release / Public Statement
Biologics
Guidance Documents
10/05/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA awards Stanford University with a research contract to study SARS-CoV-2.
Daily Roundup
Medical Devices
Research
10/02/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA posts transcript of Dr. Stephen M. Hahn, M.D.’s remarks to the National Consumers League, issues warning letter against unapproved and misbranded product related to COVID-19.
Daily Roundup
Medical Devices
Drugs
10/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA revises an emergency use authorization, plus a warning letter to caution consumers against unapproved and misbranded products related to COVID-19.
Daily Roundup
Medical Devices
Drugs
09/30/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues a new warning letter, a new FDA Voices and updates the SARS-CoV-2 reference panel comparative data in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
Drugs
09/30/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
09/29/2020
Dr. Hahn’s remarks to the National Consumers League on the vaccine review process
Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA
Event
Biologics
09/29/2020
A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response
CDRH’s response to the pandemic has been unprecedented in terms of volume, speed, and agility, including regulatory flexibility and EUAs.
FDA Voices: Leadership Perspectives
Medical Devices
09/29/2020
Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
The FDA, CDC, NIOSH, and OSHA will host a webinar on Respirators and Other PPE for Health Care Personnel Use during the COVID-19 Pandemic.
Event
Medical Devices
09/25/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues an updated summary of the agency’s COVID-19 response efforts.
Daily Roundup
Drugs
Biologics
Food & Beverages
Imports
Medical Devices
09/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a re-issued EUA, an update to the Device Discontinuance List and new health education materials in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
09/23/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19
Today, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
Press Release / Public Statement
Medical Devices
09/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a new summary of evidence to support an EUA and FDA Commissioner Stephen M. Hahn’s testimony before a Senate committee in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
09/23/2020
COVID-19: An Update on the Federal Response
Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testifies for the FDA.
Written Testimony | Commissioner Hahn’s Opening Remarks
Event
Biologics
Drugs
Food & Beverages
Medical Devices
09/23/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
09/21/2020
Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
Learn more about how to identify fraudulent claims and false information on products that claim to diagnose, treat, or prevent coronavirus.
Consumer Information
Biologics
Drugs
Medical Devices
09/21/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a new video for consumers and an updated guidance in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
Guidance Documents
Medical Devices
09/18/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s action on a reissued Emergency Use Authorization in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
09/17/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a new abbreviated drug application approval and a warning to consumers and health care professionals in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
09/16/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a new abbreviated drug application approval and published comparative performance data for COVID-19 molecular diagnostic tests in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
09/16/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
09/15/2020
FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
The FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests.
Press Release / Public Statement
Medical Devices
09/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues two warning letters in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Warning Letters
09/15/2020
Webinar Series – Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic
The FDA will present information on both the enforcement policy and the EUA for gowns and other apparel, and representatives from the FDA, CDC, and OSHA will be available to answer your questions.
Event
Medical Devices
09/14/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA awards a new research contract in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Research
Medical Devices
09/14/2020
FDA and global partners to analyze coronavirus samples
Effort to help inform development of SARS-COV-2 diagnostics, vaccines, and therapeutics
Press Release / Public Statement
Research
09/11/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues a temporary guidance and an FDA Voices in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Animal & Veterinary
Biologics
Drugs
Guidance Documents
09/11/2020
The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health
FDA is committed to making decisions regarding the authorization or approval of COVID-19 vaccines that are guided by science and data.
FDA Voices: Leadership Perspectives
Biologics
09/10/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s action on a warning letter in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Warning Letters
09/10/2020
Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
FDA Principal Deputy Commissioner Amy P. Abernethy, M.D., Ph.D., discusses the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our pandemic response.
Event
Biologics
Drugs
Medical Devices
09/09/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues a consumer update on the Food and Cosmetics Information Center in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Food & Beverages
Medical Devices
09/09/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
he purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
Imports
09/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA deactivated the FDA registration for more than 300 foreign establishments in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
09/04/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues an updated COVID-19 Response At-A-Glance Summary in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
09/03/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA expands language availability for consumer updates in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
09/02/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s actions on a warning letter, an approved abbreviated new drug application, and an updated guidance in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
09/02/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
09/01/2020
The Opioid Epidemic and COVID-19 Pandemic
Megan Moncur, the FDA’s Associate Director of Opioid Policy, discusses the opioid epidemic and how it’s been impacted by the COVID-19 pandemic.
Podcast / Video
Drugs
09/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA’s action on a warning letter in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
09/01/2020
Webinar Series – CDC/NIOSH’s Surgical N95 Respirator Guidance
CDC/NIOSH will present information on the guidance, and representatives from the CDC/NIOSH, FDA, and Occupational Safety and Health Administration (OSHA) will be available to answer questions about this guidance
Event
Medical Devices
Guidance Documents
08/31/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on an emergency use authorization and a letter to health care providers in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
08/28/2020
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020.
Press Release / Public Statement
Biologics
08/28/2020
COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19
The scope of the existing EUA was broadened to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
Press Release / Public Statement
Drugs
08/28/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA approves an abbreviated new drug application for sedated and ventilated patients during the COVID-19 public health emergency.
Daily Roundup
Drugs
08/27/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA issues a new warning as alcohol-based hand sanitizers are being packaged to appear as food or drink, putting consumers at risk.
Daily Roundup
Drugs
Medical Devices
08/27/2020
COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
FDA is warning consumers about hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.
Press Release / Public Statement
Drugs
08/26/2020
COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
The FDA issued an EUA for the first COVID-19 diagnostic that can be run without an analyzer.
Press Release / Public Statement
Medical Devices
08/26/2020
Coronavirus (COVID-19) Update: Daily Roundup
The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., discussing drug shortages during the COVID-19 pandemic.
Daily Roundup
Drugs
08/25/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues new Consumer Update and approves an Abbreviated New Drug Application during COVID-19 pandemic.
Daily Roundup
Drugs
08/25/2020
FDA Insight: Drug Shortages and COVID-19
Valerie Jensen, the Associate Director of the Drug Shortages staff in FDA’s Center for Drug Evaluation and Research, joins Deputy Commissioner Dr. Anand Shah for a discussion on drug shortages and how the COVID-19 pandemic can impact the drug supply chain.
Podcast / Video
Drugs
08/24/2020
Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
FDA testing uncovered toxic ingredients in some hand sanitizers – find out if your product on the list
Consumer Information
Safety Information
Drugs
08/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA provides new webpage with available COVID-19 testing resources.
Daily Roundup
Medical Devices
08/23/2020
FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic
Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.
Press Release / Public Statement
Biologics
08/21/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues new emergency use authorization, plus letter to healthcare providers (HCP) as the COVID-19 public health emergency continues.
Daily Roundup
Medical Devices
08/20/2020
FDA Leadership to Accelerate the Recovery from COVID-19
Remarks by Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. to the Alliance for Health Policy
Event
Biologics
Drugs
Medical Devices
08/20/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA releases new checklist and guidance as COVID-19 continues to impact drug development programs and the food industry.
Daily Roundup
Biologics
Drugs
Medical Devices
08/19/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA provides FAQs on UV lights and lamps for disinfection during the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/18/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA provides supporting information on respirators for healthcare providers and manufacturers amid COVID-19 pandemic.
Daily Roundup
Medical Devices
08/18/2020
Health Fraud and COVID-19
Dr. Judy McMeekin, the Associate Commissioner for Regulatory Affairs, joins Dr. Shah on the show to discuss FDA’s fight against health fraud during the COVID-19 pandemic.
Podcast / Video
Biologics
Drugs
Medical Devices
Warning Letters
08/17/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues an emergency use authorization (EUA) for saliva sample COVID-19 diagnostic test.
Daily Roundup
Medical Devices
08/15/2020
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing
The FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples.
Press Release / Public Statement
Medical Devices
08/14/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA provides device shortage list and issues an updated FDA COVID-19 Response-At-A-Glance-Summary as pandemic evolves.
Daily Roundup
Medical Devices
08/13/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues warning about certain hand sanitizer products amid COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
08/12/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on consumer tips, warning letters, emergency use authorizations, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/11/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuing warning statements and warning letters; issuing Emergency Use Authorizations for tests; posting new FAQ webpages on the registration and listing, and importing of medical devices; and more, in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
08/10/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, Emergency Use Authorizations, contaminated hand sanitizers, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
08/10/2020
The Critical Role of Health Care Practitioners during COVID-19
Remarks by FDA Commissioner Stephen M. Hahn, M.D., as prepared for a video conversation with health professionals.
Event
Biologics
Drugs
Medical Devices
08/07/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on revocation of EUAs, updates on the Coronavirus Treatment Acceleration Program, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
08/06/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the issuance of ventilator- and face-mask-related emergency use authorizations and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/05/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/05/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
08/04/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, issuances of emergency use authorizations and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/04/2020
Webinar Series – FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic
During this webinar, representatives from the FDA will share information and answer questions related to face masks and surgical masks.
Event
Medical Devices
08/03/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuing emergency use authorizations for serology tests and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
08/03/2020
Investing in Advanced Manufacturing to Support Public Health Preparedness
Advanced manufacturing provides an approach for protecting our supply chain and improving our response capacity during crisis situations.
FDA Voices: Leadership Perspectives
Biologics
Drugs
Medical Devices
07/31/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
The FDA authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests are known as “semi-quantitative” tests.
Press Release/ Public Statement
Medical Devices
07/31/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/30/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on FAQs on food safety, serology and remdesivir and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Food & Beverages
Drugs
Medical Devices
07/29/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on updated molecular diagnostic templates for labs and industry preparing EUA requests, templates for commercial developers submitting EUA requests for at-home diagnostic tests, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/29/2020
Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools
The new template will help commercial developers prepare and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab.
Press Release / Public Statement
Medical Devices
07/28/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on vaccines, molecular-based diagnostic tests and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
07/28/2020
FDA Insight: Vaccines for COVID-19, Part 2
Dr. Peter Marks returns for a more comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode.
Podcast / Video
Biologics
07/27/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuance of emergency use authorizations for tests including for asymptomatic people, pooling data, and qualitative detection of antibodies; contaminated hand sanitizer; and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/27/2020
Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
The FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol.
Press Release / Public Statement
Drugs
07/24/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
The FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing.
Press Release / Public Statement
Medical Devices
07/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuances of emergency use authorizations, tests, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, testing supply substitution strategies and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/22/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on updated FAQs on test EUAs, cancer, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/22/2020
FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
FDA and Syapse presented Real-World Data at the American Association of Clinical Research (AACR) COVID-19 and Cancer meeting. Findings from study reveal higher risk of hospitalization and death among cancer patients with COVID-19.
Press Release / Public Statement
Drugs
07/22/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
07/21/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on health fraud, issuances of emergency use authorizations (EUAs) for test development, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
07/21/2020
FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
The FDA’s actions are providing stakeholders with accurate information about COVID-19 diagnostic test performance and allowing for the rapid availability of tests.
FDA Voices: Leadership Perspectives
Medical Devices
07/21/2020
FDA Insight: Vaccines for COVID-19, Part 1
In Part 1 of FDA Insight’s vaccine series, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, to discuss the basics of COVID-19 vaccine development.
Podcast / Video
Biologics
07/21/2020
Webinar Series – Respirators for Health Care Personnel Use During the COVID-19 Pandemic
Representatives from FDA, NIOSH, and OSHA will answer questions.
Event
Medical Devices
07/21/2020
Protecting Americans from COVID-19 Scams
Written testimony presented by Catherine Hermsen, Assistant Commissioner, FDA Office of Criminal Investigations, before the Senate Subcommittee on Manufacturing, Trade, and Consumer Protection, Committee on Commerce, Science, and Transportation
Event
Drugs
Medical Devices
07/20/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on consumer fraud; reissuance of an EUA for a diagnostic test; guidance for transport media; extension of enforcement discretion for human cell, tissue, and cellular and tissue-based products; and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
07/20/2020
FDA Protects Patients and Consumers from Fraud During COVID-19
The FDA’s consumer protection work is a cornerstone of our mission and a critical component of our pandemic response efforts.
FDA Voices: Leadership Perspectives
Drugs
Medical Devices
07/18/2020
Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
FDA issued first emergency authorization for sample pooling in COVID-19 diagnostic testing to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test.
Press Release / Public Statement
Medical Devices
07/17/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuing Emergency Use Authorizations for tests, warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/16/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on hand sanitizer recalls, testing-related emergency use authorizations, Industry Hotline closure, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on Frequently Asked Questions on Testing for SARS-CoV-2 and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/15/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers developing diagnostic tests for SAR-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
07/14/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on treatment acceleration, drug compounding, warning letters, hand-sanitizer quiz, therapeutics, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/14/2020
An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
FDA’s Coronavirus Treatment Acceleration Program (CTAP) leverages cross-agency scientific resources and expertise to bear on COVID-19 therapeutic development and review.
FDA Voices: Leadership Perspectives
Biologics
Drugs
07/14/2020
FDA Insight Podcast: Clinical Trials and Treatments for COVID-19
Dr. Patrizia Cavazzoni, the acting director of FDA’s Center for Drug Evaluation and Research, joins Dr. Shah for an in-depth discussion on clinical trials and treatments for COVID-19. A list of clinical trials are available at ClinicalTrials.gov.
Podcast / Video
Biologics
Drugs
07/13/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on vaccine research, issuances of emergency use authorizations, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/10/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on resumption of domestic inspections, issuance of Emergency Use Authorizations for molecular diagnostic tests, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
07/10/2020
Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
The FDA is preparing for resumption of domestic inspections with a new risk assessment system.
Press Release / Public Statement
Inspections
07/09/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions against a seller/distributor of unapproved or misbranded products and more in the agency’s ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, criminal charges, methanol-contaminated hand sanitizers, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/08/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
07/07/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, false positive test results, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/07/2020
FDA Insight: Food Safety and COVID-19
FDA Commissioner Stephen M. Hahn, M.D., returns to FDA Insight to discuss food safety issues during the COVID-19 pandemic.
Podcast / Video
Food & Beverages
07/06/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on diagnostic tests, including authorizations, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
Medical Devices
07/06/2020
Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test
The FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
Press Release / Public Statement
Medical Devices
07/02/2020
Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season
The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season.
Press Release / Public Statement
Medical Devices
07/02/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on methanol-contaminated hand sanitizers, the FDA COVID-19 Response At-A-Glance Summary, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
07/02/2020
Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products.
Press Release / Public Statement
Drugs
07/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on issuance of testing-related emergency use authorizations, warning letters, diagnostic reference panel materials, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/30/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on vaccine development and licensure guidance, emergency use authorizations, diagnostics, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
06/30/2020
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
The FDA published a guidance document to facilitate the timely development of safe and effective vaccines to prevent COVID-19, giving recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.
Press Release / Public Statement
Biologics
Guidance Documents
06/30/2020
COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School
Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified for the FDA.
Written testimony
Event
Biologics
Drugs
Food & Beverages
Medical Devices
06/30/2020
FDA Insight Podcast: All About COVID-19 Testing
Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, welcomes Toby Lowe, the Associate Director of the Office of In Vitro Diagnostics and Radiological Health, to discuss the basics of diagnostic tests for COVID-19.
Podcast / Video
Medical Devices
06/29/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, Emergency Use Authorizations, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/26/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, lab and manufacturer EUA submission templates for serology tests, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/25/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on ventilator emergency use authorizations, partnering with the European Union and Global regulators, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
06/25/2020
Partnering with the European Union and Global Regulators on COVID-19
The FDA and the European Union, including the European Commission and its European Medicines Agency, are collaborating on many scientific and regulatory fronts as part of our COVID-19 response.
FDA Voices: Leadership Perspectives
Biologics
Drugs
Medical Devices
06/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on food safety, launch of new “FDA Insight” podcast, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Food & Beverages
Medical Devices
06/24/2020
Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19
U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19.
Press Release / Public Statement
Food & Beverages
06/24/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
06/23/2020
FDA Insight Podcast: Fighting COVID-19 at the FDA
In this first episode of a new podcast series, FDA Commissioner Dr. Stephen Hahn, and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah discuss FDA’s COVID-19 efforts, including the drug development process for a COVID-19 treatment.
Podcast / Video
Drugs
06/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on food safety, the CURE Drug Repurposing Collaboratory, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
06/23/2020
FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic
FDA is currently on target to meet our user fee goals for drugs this year. We have reviewed and taken timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.
FDA Voices: Leadership Perspectives
Drugs
06/23/2020
House Committee on Energy & Commerce Hearing: Oversight of the Trump Administration’s Response to the COVID-19 Pandemic
FDA Commissioner Stephen M. Hahn, M.D., will be testifying for the FDA.
Written testimony
Event
Medical Devices
Biologics
Drugs
Food & Beverages
06/23/2020
Webinar Series – Respirators for Health Care Personnel Use during COVID-19 Pandemic
The FDA will host the second webinar in the webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic.
Event
Imports
Medical Devices
06/22/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters as well as guidance on formal meetings, user-fee applications for medical devices, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/19/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions including its At-A-Glance Summary, a public-private partnership fostering innovation in devices and PPE, warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/18/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on a web resource listing EUAs, the CURE ID app, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
06/18/2020
FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
The FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.
Press Release / Public Statement
Medical Devices
06/17/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, statistical issues related to clinical trials, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/17/2020
Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.
Press Release / Public Statement
Medical Devices
06/16/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on an online portal for adverse event reporting on EUA devices or COVID-19-related guidance and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
06/16/2020
Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
Today, the FDA posted template updates on the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.
Press Release / Public Statement
Medical Devices
06/16/2020
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test
Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.
Press Release / Public Statement
Medical Devices
06/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on EUAs (hydroxychloroquine, chloroquine), remdesivir drug interaction alert, pet safety, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Animal & Veterinary
06/15/2020
Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use
Today, the FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease.
Press Release / Public Statement
Drugs
06/15/2020
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
Press Release / Public Statement
Drugs
06/12/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, an EUA for a point-of-care diagnostic test, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Medical Devices
06/11/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on continuing priorities regarding rare diseases, health-fraud warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/11/2020
Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19
FDA’s work to advance treatments for rare diseases and helping ensure continuity of care for people with rare diseases remain top priorities during COVID-19.
FDA Voices: Leadership Perspectives
Biologics
Drugs
Medical Devices
06/10/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on updates to the CURE ID crowd-sourcing app, an EUA for the first COVID-19 diagnostic test utilizing next-generation gene sequencing, and more in FDA’s ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
06/10/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology.
Press Release / Public Statement
Medical Devices
06/09/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters regarding fraudulent products, approval of an abbreviated new drug application for a drug to facilitate tracheal intubation, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/09/2020
Webinar: CURE ID- Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19
This webinar will demonstrate CURE ID – a mobile app and web platform, that gives the global clinical community the opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19.
Event
Drugs
06/09/2020
Webinar Series: Respirators for Health Care Personnel Use during COVID-19 Pandemic
The FDA will kick off a webinar series to share information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help assure health care personnel have the necessary supplies of respirators.
Event
Medical Devices
06/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on PDMA guidance on prescription drug sample distributions, respirator decontamination EUAs, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/07/2020
Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination.
Press Release / Public Statement
Medical Devices
06/05/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on guidance for non-invasive patient monitoring to decrease infection risk, summary of FDA COVID-19 response, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
06/04/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on test performance data, warning letters, video explaining test types, respirators for health care personnel webinar, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/04/2020
Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study
Today, the FDA publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).
Press Release / Public Statement
Medical Devices
06/03/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on clinical trials guidance, testing supply substitution strategies, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/03/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
06/02/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on food safety (FDA Voices by Commissioner S. Hahn, Deputy Commissioner F. Yiannis), guidance on single-member IRBs, authorized NASA ventilator and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
06/02/2020
COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process
FDA officials Judith A. McMeekin, Mark Abdoo, and Douglas Throckmorton testimony before the U.S. Senate Committee on Finance
Event
Drugs
Inspections
06/02/2020
Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety
The FDA will release the New Era of Smarter Food Safety Blueprint in the coming weeks, outlining our plans over the next decade to create a more digital, traceable, and safer food system.
FDA Voices: Leadership Perspectives
Food & Beverages
06/01/2020
Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
Today, the FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
Press Release / Public Statement
Drugs
06/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA Voices (EUAs), consumer update on regulatory terminology and more on FDA’s ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
06/01/2020
Remarks by Commissioner Stephen Hahn, M.D.—The COVID-19 Pandemic—Finding Solutions, Applying Lessons Learned
Commissioner Hahn speaks to the Alliance for a Stronger FDA
Event
Biologics
Drugs
Food & Beverages
Medical Devices
05/29/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on EUAs, warning letters, health fraud, informed consent, clinical trials and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
05/29/2020
Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic
FDA Commissioner Stephen M. Hahn, M.D., on the FDA’s role in facilitating treatment options during the public health response to the COVID-19 pandemic.
FDA Voices: Leadership Perspectives
Drugs
Biologics
05/29/2020
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
Find information about the terms used to describe possible COVID-19 preventions or treatments and what they mean.
Consumer Information
Drugs
Biologics
05/29/2020
Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.
Press Release / Public Statement
Medical Devices
05/28/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on EUAs, N95 respirators, COVID-19 diagnosis, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
05/27/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on guidance for industry, warning letters, testing updates, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
Food & Beverages
Guidance Documents
Medical Devices
Warning Letters
05/27/2020
Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
FDA provides SARS-CoV-2 reference panel to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.
Press Release / Public Statement
Biologics
Medical Devices
05/27/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA will host a virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
05/26/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on antibody testing updates, new abbreviated new drug applications, guidance on medical devices and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
05/22/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on PPE recommendations for the food and agriculture industry, testing updates, warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Food & Beverages
Medical Devices
Warning Letters
05/21/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on antibody testing updates, new abbreviated new drug applications, guidance on medical devices and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Tobacco Products
05/21/2020
Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Press Release / Public Statement
Medical Devices
05/20/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, MOU with USDA and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Dietary Supplements
Drugs
Food & Beverages
Medical Devices
Warning Letters
05/20/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
05/19/2020
USDA, FDA Strengthen U.S. Food Supply Chain Protections
As the COVID-19 pandemic response continues, the USDA and the FDA have been working around the clock on many fronts to support the U.S. food and agriculture sector so that Americans continue to have access to a safe and robust food supply.
Press Release / Public Statement
Food & Beverages
05/19/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on diagnostics, succinylcholine chloride injection approval and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
05/19/2020
Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
The FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
05/18/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, supply chain update, first standalone at-home sample collection kit EUA and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
Warning Letters
05/16/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
The FDA has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.
Press Release / Public Statement
Medical Devices
05/15/2020
Consumer Update: Coronavirus Testing Basics
Learn more about the different types of coronavirus tests and what they mean. Print out a PDF version of this information.
Consumer Information
Medical Devices
05/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, industry hotline hours, diagnostics and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
Medical Devices
Warning Letters
05/15/2020
Virtual Town Hall – 3D Printed Swabs
The FDA will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.
Event
Medical Devices
05/14/2020
COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products
A critical part of the FDA’s work is ensuring the safety and security of the U.S. supply of food and medical products during COVID-19.
FDA Voices: Leadership Perspectives
Imports
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
05/14/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on infusion pump EUAs, drug compounding guidance and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
05/14/2020
Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test
Today, the FDA is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19.
Press Release / Public Statement
Medical Devices
05/14/2020
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19
A federal court has entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three individuals associated with the entity, requiring them to immediately stop distributing colloidal silver products.
Press Release / Public Statement
Dietary Supplements
Drugs
05/13/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on an upcoming town hall on 3D printing, thermal imaging and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
05/13/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
05/12/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on treatment acceleration, inspection updates and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Inspections
Biologics
Medical Devices
Warning Letters
05/12/2020
Hearing – COVID-19: Safely Getting Back to Work and Back to School
FDA Commissioner Stephen M. Hahn testified before the U.S. Senate Committee on Health, Education, Labor and Pensions
Event
Drugs
Biologics
Medical Devices
05/12/2020
COVID-19 Social Media Toolkit
Resources in English and Spanish for sharing information about COVID-19 and the FDA response to the pandemic.
Safety Information
Consumer Information
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
05/11/2020
Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
Today, the FDA took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area.
Press Release / Public Statement
Biologics
Drugs
05/11/2020
Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19
During COVID-19, the FDA will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections.
Press Release / Public Statement
Inspections
05/11/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the first antigen test, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Warning Letters
05/09/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients
The FDA has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic.
Press Release / Public Statement
Medical Devices
05/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the first at-home saliva test, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
Warning Letters
05/08/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.
Press Release / Public Statement
Medical Devices
05/07/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on new guidances, warning letters, updated EUAs for non-NIOSH approved respirators manufactured in China and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Animal & Veterinary
Medical Devices
Warning Letters
05/07/2020
Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products
Today, the FDA is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.
Press Release / Public Statement
Drugs
Medical Devices
05/06/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on device manufacturing guidance, diagnostics and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
05/05/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, generic drug approvals and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Warning Letters
05/04/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on an updated serology policy, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
05/04/2020
Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
Today, the FDA announced important updates to our March 16, 2020 policy on commercial manufacturers’ serology—or antibody—tests for #COVID19. Under the new policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of the updated policy publication date, or the date they notify FDA of their test validation, whichever is later.
FDA Voices: Leadership Perspectives
Medical Devices
05/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the remdesivir EUA, convalescent plasma guidance, grocery shopping safety tips and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Food & Beverages
05/01/2020
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
FDA has issued emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
Press Release / Public Statement
Drugs
04/30/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on new EUAs including an innovative ventilator developed in partnership with NASA, consumer update on pets, drug supply guidance and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Animal & Veterinary
04/30/2020
Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets
Questions and answers to help keep you, your family, and your pets safe during the pandemic.
Consumer Information
Animal & Veterinary
04/30/2020
Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization
The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.
Press Release / Public Statement
Medical Devices
04/30/2020
Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency
FDA will discuss the challenges of, and guidance for, supporting clinical trials during the COVID-19 public health emergency. Note: This webinar is now full, but the recording of the webinar will be available shortly after the webinar concludes.
Event
Drugs
04/30/2020
Remarks by FDA Commissioner Stephen M. Hahn, M.D., to the 2020 MDMA Annual Meeting
Event
Medical Devices
04/29/2020
Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic
The newly updated Nutrition Facts Label can help you and your family eat healthy when daily routines change.
Consumer Information
Food & Beverages
04/29/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on nutrition consumer updates, accelerated approval of new dosing for cancer regimens, EUAs on serology validation and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Food & Beverages
04/28/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, video resources on EUAs and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Tobacco Products
Warning Letters
04/27/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on hand sanitizer safety information, food production fact sheets and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Food & Beverages
04/27/2020
Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns
Today, the FDA provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic.
Press Release / Public Statement
Drugs
04/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on drug safety confirmation, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
Drugs
Warning Letters
04/24/2020
Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
FDA is reiterating the importance of close patient supervision for ‘off-label’ use of antimalarial drugs to mitigate known risks, including heart rhythm problems.
Press Release / Public Statement
Drugs
04/23/2020
CTTI Webinar: Designing High-Quality COVID-19 Treatment Trials
FDA participated in a discussion of the current landscape of COVID-19 treatment trial designs and best practices for quickly launching trials that ensure both patient safety and reliable results.
Event
Drugs
04/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on new guidances, Spanish resources for grocery shopping and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
Food & Beverages
Guidance Documents
04/23/2020
Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19
As a result of the COVID-19 pandemic, FDA requested and was granted by the court, a 120-day extension of the May 12 deadline for premarket applications for e-cigarettes, cigars and other new tobacco products. These premarket applications are now required to be filed by Sept. 9, 2020.
Press Release / Public Statement
Tobacco Products
04/22/2020
Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The purpose of this virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
04/22/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on remote monitoring EUAs, warning letters on fraudulent products and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Warning Letters
Guidance Documents
04/21/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the first diagnostic test with an at-home sample collection options, food supply and safety information and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Food & Beverages
Medical Devices
04/21/2020
FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19
The FDA is working closely with the food industry and USDA to provide flexibility regarding federal food labeling so consumers have access to the food they want.
FDA Voices: Leadership Perspectives
Food & Beverages
04/21/2020
Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection
The FDA authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
Press Release / Public Statement
Medical Devices
04/20/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on recent agency guidance, the Coronavirus Treatment Acceleration Program, new EUAs for face masks and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Guidance Documents
04/20/2020
The Path Forward: Coronavirus Treatment Acceleration Program
The FDA has launched a new program called the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful.
FDA Voices: Leadership Perspectives
Drugs
Biologics
04/18/2020
Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts
Given the active dialogue about serological tests that are currently on the market, and their significance in the nation’s response efforts, we’d like to provide further details about our thinking on these tests and our approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims.
Press Release / Public Statement
Safety Information
Medical Devices
04/17/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on vaccine public-private partnerships, warning letters, EUAs and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Warning Letters
04/17/2020
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
A federal court has entered a temporary injunction requiring Genesis to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases.
Press Release / Public Statement
Drugs
04/17/2020
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
The FDA will participate in the ACTIV partnership aimed at developing a collaborative framework among all partners to rapidly respond to COVID-19 and future pandemics.
Press Release / Public Statement
Biologics
Drugs
Medical Devices
04/16/2020
Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs
The FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.
Press Release / Public Statement
Medical Devices
04/16/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on guidances, warning letters, food safety resources, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Animal & Veterinary
Food & Beverages
Guidance Documents
Warning Letters
04/16/2020
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
The FDA’s User Fee programs help us fulfill our mission to protect public health while also helping to accelerate innovation in industry and bring new treatment options to the American public.
Press Release / Public Statement
Drugs
Biologics
Medical Devices
Animal & Veterinary
04/16/2020
Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies
The FDA is providing an update on one potential treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.
Press Release / Public Statement
Biologics
04/15/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on new serology EUAs, warning letters, consumer resources and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Guidance Documents
Warning Letters
04/15/2020
Remarks by FDA Commissioner Stephen M. Hahn, M.D., to the 2020 Rx Drug Abuse and Heroin Summit
Event
Drugs
Biologics
Medical Devices
04/14/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on warning letters, updated consumer information on testing, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Warning Letters
04/13/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on product-specific guidances, news EUAs, hand sanitizer information and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Guidance Documents
04/12/2020
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators
The FDA issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.
Press Release / Public Statement
Medical Devices
04/10/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on new EUAs for blood purification devices and PPE decontamination, warning letters and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Guidance Documents
Warning Letters
04/10/2020
A Perspective on the FDA’s COVID-19 Response
The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
FDA Voices: Leadership Perspectives
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
04/10/2020
Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators
The FDA issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
Press Release / Public Statement
Medical Devices
04/10/2020
Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19
The FDA issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
Press Release / Public Statement
Medical Devices
Biologics
04/09/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on guidance for portable cryogenic containers during this public health emergency, warning letters, best practices for retail food stores, restaurants, and pickup and delivery services, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Food & Beverages
Medical Devices
Guidance Documents
Warning Letters
04/08/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on recommendations on the administration and study of convalescent plasma, warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Biologics
Medical Devices
Warning Letters
04/08/2020
Coronavirus (COVID-19) Update: FDA Warns Company Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19
The FDA has issued a warning letter to a company that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19).
Press Release / Public Statement
Drugs
Warning Letters
04/07/2020
Coronavirus (COVID-19) Update: Serological Tests
Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19.
Press Release / Public Statement
Medical Devices
04/07/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues new guidance documents for remote ophthalmic assessment and monitoring devices, ECMO and cardiopulmonary bypass devices, temporary policy regarding enforcement of the Egg Safety Rule, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
Food & Beverages
Drugs
Guidance Documents
04/06/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA issues new guidance on clinical electronic thermometers and infusion pumps and accessories and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Medical Devices
Guidance Documents
04/06/2020
Webinar: Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance
On April 6, 2020, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19.
Event
Medical Devices
Guidance Documents
04/03/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on convalescent plasma, a new EUA for non-NIOSH-approved respirators made in China, flexibility regarding the packaging and labeling of shell eggs, and more in its ongoing response to the COVID-19 pandemic
Daily Roundup
Biologics
Medical Devices
Animal & Veterinary
Food & Beverages
Guidance Documents
04/03/2020
Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19
The FDA is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.
Press Release / Public Statement
Biologics
04/02/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on blood donor eligibility, authorizing the first serology test to date, informing the public on food safety and the food supply, and more in its ongoing response to the COVID-19 pandemic
Daily Roundup
Biologics
Food & Beverages
Drugs
Medical Devices
Guidance Documents
Warning Letters
04/02/2020
FDA Commissioned Corps Officers on the Front Line of COVID-19 Response
Almost 400 FDA Commissioned Corps officers have been deployed to aid in response to the coronavirus public health emergency.
FDA Voices: Leadership Perspectives
04/02/2020
Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
The FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.
Press Release / Public Statement
Biologics
Guidance Documents
04/01/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data, temporary flexibility to chain restaurants and similar retail food establishments, warning letters, and more in its ongoing response to the COVID-19 pandemic
Daily Roundup
Medical Devices
Food & Beverages
Drugs
Guidance Documents
03/31/2020
FDA: Food Access and COVID-19
Food availability and food safety are vitally important to our well-being, and the FDA is working hard to help ensure the foods you, your family, and your pets eat are safe and available during the COVID-19 pandemic.
Video Length: 1:20
Safety Information
Food & Beverages
03/31/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on the Coronavirus Treatment Acceleration Program, shortages of hydroxychloroquine and chloroquine, warning letters, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Warning Letters
03/31/2020
Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
The FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.
Press Release / Public Statement
Drugs
Biologics
03/30/2020
Coronavirus (COVID-19) Update: Daily Roundup
FDA actions on hydroxychloroquine sulfate and chloroquine phosphate products, N95 respirators, surgical apparel for health care professionals, and more in its ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Guidance Documents
Warning Letters
03/30/2020
Virtual Town Hall Series – Topic: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
On April 1, 2020, the FDA will host the first of a series of virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.
Event
Medical Devices
Guidance Documents
03/30/2020
Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19
The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.
Press Release / Public Statement
Medical Devices
03/30/2020
FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.
Press Release / Public Statement
Drugs
03/28/2020
Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products
The FDA is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response.
Press Release / Public Statement
Medical Devices
Drugs
Biologics
Animal & Veterinary
Food & Beverages
Imports
03/27/2020
Coronavirus (COVID-19) Update: Daily Roundup
Actions by the FDA in our ongoing response to the COVID-19 pandemic
Daily Roundup
Drugs
Biologics
Food & Beverages
Medical Devices
Guidance Documents
03/27/2020
Food Safety and Availability During the Coronavirus Pandemic
There is no evidence of food or food packaging being associated with transmission of the coronavirus. Currently there are no food shortages nationwide, although certain foods may be temporarily out of stock.
Safety Information
Food & Beverages
03/27/2020
Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients
The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19.
Press Release / Public Statement
Medical Devices
03/27/2020
Safely Using Hand Sanitizer
You can help stop the spread of COVID-19 by washing your hands with soap and water; if soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.
Consumer Information
Drugs
03/26/2020
Coronavirus (COVID-19) Update: Daily Roundup
Actions by the FDA in our ongoing response to the COVID-19 pandemic.
Daily Roundup
Food & Beverages
Drugs
Medical Devices
Guidance Documents
03/25/2020
FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 Response Public-Private Partnership
The FDA entered a Memorandum of Understanding (MOU) with the VA Innovation Ecosystem and the NIH 3D Print Exchange, to share data and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes to provide resources that will connect health care providers and 3D printing organizations.
Safety Information
Medical Devices
03/25/2020
Coronavirus (COVID-19) Update: Daily Roundup
Actions by the FDA in our ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
Guidance Documents
03/24/2020
Coronavirus (COVID-19) Update: Daily Roundup
Actions by the FDA in our ongoing response to the COVID-19 pandemic.
Daily Roundup
Biologics
Drugs
Medical Devices
Animal & Veterinary
Food & Beverages
03/24/2020
FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19
The U.S. food supply remains safe for both people and animals during the COVID-19 pandemic.
FDA Voices: Leadership Perspectives
Animal & Veterinary, Food & Beverages
03/24/2020
Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.
Press Release / Public Statement
Medical Devices
Imports
03/24/2020
Investigational COVID-19 Convalescent Plasma – Emergency INDs
Information for healthcare providers about convalescent plasma—plasma collected from the blood of fully recovered COVID-19 patients and given as treatment to very ill COVID-19 patients.
Safety Information
Biologics
03/24/2020
Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic
The FDA announced today that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.
Press Release / Public Statement
Animal & Veterinary
03/23/2020
Coronavirus (COVID-19) Update: Daily Roundup
Actions by the FDA in our ongoing response to the COVID-19 pandemic.
Daily Roundup
Drugs
Medical Devices
03/23/2020
FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development
FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.
FDA Voices: Leadership Perspectives
Biologics
03/22/2020
Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency
The FDA issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
Press Release / Public Statement
Drugs
03/22/2020
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
The FDA took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
Press Release / Public Statement
Medical Devices
03/21/2020
Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
The FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
Press Release / Public Statement
Medical Devices
03/20/2020
Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.
Press Release / Public Statement
Medical Devices
Warning Letters
03/20/2020
Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19)
Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions are now available in Spanish.
Safety Information
Consumer Information
03/20/2020
Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely
The FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.
Press Release / Public Statement
Medical Devices
03/20/2020
Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health
As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
Press Release / Public Statement
Drugs
Guidance Documents
03/19/2020
DHS Issues Guidance on the Essential Critical Infrastructure Workforce
The Department of Homeland Security (DHS)/Cybersecurity & Infrastructure Agency (CISA) issued new guidance to support state, local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions Americans depend on daily and need to be able to operate resiliently during the COVID-19 pandemic response. This includes essential workers in the food, health care, and public health sectors, including FDA-regulated industries.
Safety Information
Food & Beverages
Biologics
Drugs
Medical Devices
03/19/2020
FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19
At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.
Safety Information
Drugs
03/19/2020
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
Press Release / Public Statement
Biologics
Drugs
03/19/2020
Coronavirus (COVID-19) Update: Blood Donations
The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. At this time the number of blood donations has been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives. In order to ensure that blood is available to those who need it most, it is important for healthy individuals who are able to donate to take the time to do so.
Press Release / Public Statement
Biologics
03/18/2020
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
For the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.
Press Release / Public Statement
Inspections
03/18/2020
Coronavirus (COVID-19) Update: FDA issues a guidance on conducting clinical trials
The FDA took steps to help industry and investigators navigate the COVID-19 pandemic and move forward with conducting clinical trials.
Press Release / Public Statement
Guidance Documents
Drugs
Biologics
Medical Devices
03/18/2020
FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19)
The FDA hosted a stakeholder call to discuss food safety and food supply questions, respond to concerns, and highlight key FDA resources for the response to the COVID-19 pandemic.
Event
Food & Beverages
03/17/2020
Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements
The FDA took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.
Press Release / Public Statement
Food & Beverages
03/16/2020
Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp
The FDA took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
Press Release / Public Statement
Medical Devices
03/16/2020
Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics
The FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.
Press Release / Public Statement
Medical Devices
Guidance Documents
03/13/2020
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher
The FDA took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit.
Press Release / Public Statement
Medical Devices
03/12/2020
Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic
The two significant actions will expedite the availability of diagnostic tests.
Press Release / Public Statement
Medical Devices
03/10/2020
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
Press Release / Public Statement
Inspections
03/09/2020
Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
The FDA and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak.
Press Release / Public Statement
Dietary Supplements, Drugs, Food & Beverages
Warning Letters
03/07/2020
Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D.
Event
Medical Devices
03/06/2020
Virtual Town Hall – Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency
The FDA hosted a town hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2.
Event
Medical Devices
03/04/2020
Remarks by FDA Commissioner Stephen Hahn to the American Clinical Laboratory Association
The Commissioner’s remarks highlighted the role of diagnostic testing in the COVID-19 response.
Event
Medical Devices
03/03/2020
HHS officials testified at a Senate HELP Hearing, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.
Remarks by Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; and Dr. Stephen Hahn, Commissioner, U.S. Food and Drug Administration
Event
Medical Devices
Biologics
Drugs
Inspections
Imports
03/02/2020
Webinar: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
The FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance.
Event
Medical Devices
Guidance Documents
03/02/2020
Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel
In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.
Press Release / Public Statement
Medical Devices
02/29/2020
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
Press Release / Public Statement
Medical Devices
Guidance Documents
02/27/2020
Coronavirus (COVID-19) Supply Chain Update
FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.
Press Release / Public Statement
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
02/24/2020
Coronavirus Update: FDA steps to ensure quality of foreign products
FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity.
Press Release / Public Statement
Imports
02/14/2020
FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
Press Release / Public Statement
Medical Devices
Drugs
Biologics
Inspections
Imports
02/11/2020
The World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease, COVID-19. FDA’s website has been updated to reflect the updated name.
Press Release / Public Statement
02/05/2020
CDC Media Telebriefing: Update on 2019 Novel Coronavirus (COVID-19), including updates from FDA Chief Scientist RADM Denise Hinton.
Press Release / Public Statement
02/04/2020
FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic
FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.
Press Release / Public Statement
Medical Devices
01/30/2020
The HHS Assistant Secretary for Preparedness and Response (ASPR) hosted a stakeholder listening session (transcript PDF) to discuss medical countermeasure challenges associated with 2019-nCoV outbreak. FDA Acting Assistant Commissioner for Counterterrorism Policy Michael Mair provided FDA remarks.
Press Release / Public Statement
Medical Devices
01/27/2020
FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures
“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
Press Release / Public Statement
Medical Devices
