Coronavirus Disease 2019 (COVID-19)
On this page:
COVID-19 Vaccines
The FDA has regulatory processes in place to facilitate the development of COVID-19 vaccines that meet the FDA's rigorous scientific standards.
FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative
A summary report on how FDA can adapt the COVID-19 response to build resilience for the future
Resources for Health Professionals
Key resources for health professionals during the COVID-19 pandemic.
Latest COVID-19 Information from the FDA
Date | Update | Type | Topic |
---|---|---|---|
01/19/2021 |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
The FDA issues an EUA, two warning letters, and more. |
COVID-19 Update | Biologics Drugs Medical Devices |
11/20/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Remarks by Dr. Stephen Hahn for the Global Pharmaceutical Manufacturing Leadership Forum |
Event | Biologics Drugs Medical Devices |
10/30/2020 |
The FDA issues a new Consumer Update. |
COVID-19 Update | Medical Devices |
10/28/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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. |
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 |
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. |
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 |
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 |
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 |
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 | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
05/01/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
04/16/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
04/06/2020 |
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 |
04/03/2020 |
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 |
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 |
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 |
03/31/2020 |
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. |
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 |
03/31/2020 |
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 |
03/30/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
03/25/2020 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.
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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 |
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 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 |
Personal Protective Equipment
Conservation strategies for PPE and other resources.
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.
Popular Coronavirus Topics
FDA Response to COVID-19
How FDA facilitates development and availability of medical countermeasures to combat COVID-19 with Medical Devices (PDF) and Therapeutics (PDF)
COVID-19 Information About FDA Regulated Products
Learn more about how FDA is facilitating the development and availability of medical countermeasures and protecting the public health.
Contact FDA
See FAQs on Diagnostic Testing for SARS-CoV-2. If you need additional information about completing the EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA, or wish to consider use of an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov.
Contact Manufacturers Assistance and Technical Training Branch (MATTB). Email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.
For therapeutics sponsors interested in submitting drug development proposals for review, see COVID-19 Therapeutics: General Information for Interested Stakeholders. Email covid19-productdevelopment@fda.hhs.gov
Please call 855-543-3784 if you are a physician who would like to request an Emergency Investigational New Drug (EIND) application for antiviral products
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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…
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