- 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 posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA’s Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020.
- In a new “FDA Voices”, entitled the FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, Peter Marks, M.D., Ph.D., highlights the value of transparency. Dr. Marks states that facilitating the development of safe and effective COVID-19 vaccines is a high priority for the FDA, and that the FDA recognizes that being transparent about the data the agency will evaluate in support of the safety and effectiveness of these vaccines, and discussing this data with the members of the Vaccines and Related Biological Products Advisory Committee, in a public forum is critical to building trust and confidence in their use by the public.
- The FDA issued a Consumer Update entitled, Advisory Committees Give FDA Critical Advice and the Public a Voice. It describes how the FDA relies on its many advisory committees to help it make sound decisions based on the best science available.
- Testing updates:
- As of today, 282 tests are authorized by FDA under EUAs; these include 220 molecular tests, 56 antibody tests, and 6 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.