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.