The FDA has been more than busy in its efforts to address the COVID-19 pandemic. Here is an update as of September 11, 2020 regarding some of the statistics the FDA has presented.
The FDA has:
- Authorized 247 tests under emergency use authorizations (EUAs), of these:
- 197 are molecular tests
- 46 are antibody tests
- 4 are antigen tests
- Issued 12 guidance documents for medical devices used in treating COVID-19 (here)
- Issued 6 temporary guidances for compounding and repackaging of drug products (here)
- Issued 110 warning letters to companies selling fraudulent, unapproved, or misbranded products purported to treat COVID-19 (here)
- Set a meeting of its Vaccines and Related Biological Products Advisory Committee on October 22nd to address the general development of COVID-19 vaccines
- As of August 31, 2020:
- The FDA reports 590+ drug development programs in planning stages.
- 310+ trials have been reviewed (safe to proceed but excludes vaccines).
- 3 COVID-19 treatments have received EUAs.
There are, of course, many related activities and statistics that could be included in this blog, but I think this gives you an idea of the FDA’s concerted effort in meeting the challenges that the COVID-19 pandemic presents. Further general information on the FDA’s activities related to the COVID-19 pandemic can be found here.