Regulatory Open Forum

 View Only
Expand all | Collapse all

Emergency Use Authorization for drugs to treat COVID-19

  • 1.  Emergency Use Authorization for drugs to treat COVID-19

    This message was posted by a user wishing to remain anonymous
    Posted 24-Mar-2021 18:00
    This message was posted by a user wishing to remain anonymous

    Dear RAPS community,

    I am looking for FDA guidance(s) regarding an EUA for drugs to treat COVID-19. I only found a guidance on vaccines to prevent COVID-19, but nothing else.
    I am really surprised.
    Did any of you have knowledge of such guidance ?

    I would appreciate any help.
    Thank you so much.

    Kind regards.


  • 2.  RE: Emergency Use Authorization for drugs to treat COVID-19

    Posted 25-Mar-2021 08:24
    On quick FDA guidance search there were 67 guidances for "COVID-19". There may be more information in one of them regarding your EUA question, for example in this one about drugs for treatment and prevention. I hope you find what you're looking for!

    ------------------------------
    Anna Sedello, PhD, RAC
    Director of Regulatory Affairs
    Redwood City CA
    United States
    ------------------------------