FDA News Release
Coronavirus (COVID-19) Update: May 4, 2021
- 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:
- The FDA Center for Drug Evaluation and Research (CDER) continually monitors our ability to meet user fee commitments. To maintain transparency during the COVID-19 public health emergency, CDER posts periodic updates to the CDER’s Work to Meet User Fee Goals During the Pandemic webpage. On May 3, CDER updated the webpage to include data from Fiscal Year 2021 Quarter 2.
- Testing updates:
- As of today, 369 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests and 23 antigen tests. There are 49 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests and two OTC at-home molecular tests.
- The FDA has authorized 8 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 481 revisions to EUA authorizations.
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.
- Amanda Turney