July 20, 2021: “The U.S. FDA announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Acting FDA Commissioner Janet Woodcock, M.D. testified before the U.S. Senate Committee on Health, Education, Labor and Pensions in a hearing titled, The Path Forward: A Federal Perspective on the COVID-19 Response.
- This week, at the FDA SBIA REdI Annual Conference, FDA leaders reflected on the FDA’s use of Emergency Use Authorizations (EUAs) and other resources in making drug, device and biological products available to support the public health response to the COVID-19 pandemic.
Day 1 External Link Disclaimer and Day 2 External Link Disclaimer recordings are now available on YouTube.
The conference continues through Friday, with additional sessions External Link Disclaimer on devices and biologics.
- Last week, the FDA held a stakeholder call to discuss COVID-19 vaccines, including preliminary reports of Guillain-Barré Syndrome following Janssen COVID-19 vaccination.
Here External Link Disclaimer is an excerpt from that call where Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research discussed the importance of getting vaccinated.
- An FDA Consumer Update, Learn More About COVID-19 Vaccines From the FDA, is now available in five additional languages: Spanish, Chinese, Korean, Tagalog, and Vietnamese. See the evidence for each COVID-19 vaccine and the reasoning behind the FDA’s Emergency Use Authorizations (EUAs).
- Testing updates:
- As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 281 molecular tests and sample collection devices, 85 antibody and other immune response tests and 30 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 576 revisions to EUA authorizations.”