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Coronavirus Disease 2019 (COVID-19)

Donate COVID-19 Plasma

If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma.

Medical Devices (PDF) | Therapeutics (PDF)

How FDA facilitates development and availability of medical devices and therapeutics to combat COVID-19.

Resources for Health Professionals

Key resources for health professionals during the COVID-19 pandemic.

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Latest COVID-19 Information from the FDA

Date Update Type Topic
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

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: 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 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 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 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 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 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

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
5/06/2020

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

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

There are currently no FDA-approved drugs, including vaccines, to treat or prevent COVID-19.

Consumer Information

Medical Devices
Drugs
Biologics

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

Emergency Use Authorizations and Guidances

Emergency Use Authorizations (EUAs)

Expedited authorization of medical products to address public health emergencies.

Guidance Documents and Policies

Policies and guidances to support rapid response to COVID-19.

Frequently Asked Questions (FAQs)

English

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

Español

Preguntas frecuentes sobre la Enfermedad del Coronavirus 2019 (COVID-19)

COVID-19 Information About FDA Regulated Products

There are currently no medical products that are approved to treat or prevent COVID-19. Learn more about how FDA is facilitating the development and availability of medical countermeasures and protecting the public health.

Contact FDA

Information From the Federal Government

Coronavirus.gov

Frequently asked questions about coronavirus disease 2019 (COVID-19), Guidelines for Opening Up America Again

Centers for Disease Control and Prevention (CDC)

How to prepare and protect yourself, what to do if you’re sick, self-checker – should you get medical care? – and more…

Occupational Safety and Health Administration

Information for workers and employers about COVID-19 from the U.S. Department of Labor

USA.gov/Coronavirus

The federal government response to COVID-19

Federal Emergency Management Agency

Information on the whole-of-America response to protect the health and safety of the American people

U.S. Department of Health & Human Services

Resources for responding to the pandemic from HHS and its federal, state, tribal, public health, and private sector partners



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