- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA reaffirmed its commitment to transparency around the EUA process and shared updates on its plan to provide more information about the agency’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines, as part of our COVID-19 response. FDA is taking additional steps to promote transparency and public confidence in the agency’s scientific review process and the appropriate use of these products authorized for emergency use by posting, to the extent appropriate and permitted by law, the scientific reviews for EUAs issued, revised, or revoked for drug and biological products. We intend to post these reviews with other EUA related materials on the FDA website.
- The FDA has reorganized the FAQs on Testing for SARS-CoV-2 webpage to make it easier to navigate to questions by topic. The agency also updated the answers to certain questions in the following sections:
- Notifications and Emergency Use Authorizations
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19
- Test Development and Review
- Test Settings
- Test Uses
- Testing Supplies
- 3D Printed Swabs
- COVID-19 Related Test Data and Reporting
- Serology/Antibody Tests
- The FDA also today published a new “FDA Insight” podcast titled “Personal Protective Equipment and COVID-19.” On this week’s episode, Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, welcomes Dr. Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health, for a discussion on PPE and its critical role in helping to reduce the spread of COVID-19.
- Testing updates:
- As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jane Hubbard