Silver Spring, MD – The U.S. Food and Drug Administration (FDA) announces the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA posted the audio and transcript versions of Episode 6 in its new podcast series, FDA Insight, which features Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research (CBER), in part 2 of a discussion on COVID-19 Coronavirus vaccines.
The podcast is hosted by Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs. Part 1 of this discussion, posted July 21st, is accessible also in audio and transcript versions as Episode 5.
FDA issued emergency use authorizations (EUAs) today for two molecular diagnostic tests for the qualitative detection of SARS-CoV-2 to:
- Eli Lilly and Company, for its Lilly SARS-CoV-2 Assay, and
- Sandia National Laboratories, for its SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay.
To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.