FDA News Release
Coronavirus (COVID-19) Update: April 13, 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:
- As the FDA celebrates National Minority Health Month, we’re working to address concerns about vaccines among diverse communities, and to protect and promote the health of diverse populations by focusing our efforts on strategies that address health disparities. Read more in a new FDA Voices: Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities.
- Testing updates:
- As of today, 358 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 262 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 21 antigen tests. There are 45 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 molecular tests.
- The FDA has authorized 7 antigen tests and 2 molecular tests for serial screening programs.
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.
- Chanapa Tantibanchachai