FDA’s Emergency Use Authorizations (EUA’s)

Discussion in 'Ask any question!' started by amberskid, Sep 7, 2022.

  1. amberskid

    amberskid New Member

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    Hi, I’m trying to find a reliable timeline for FDA’s Emergency Use Authorizations (EUA’s). With FDA’s BLA and NDA applications, it’s 10 months or 6 months with Priority Review. But I can’t find anything on EUA’s except for a very general “it can be fast” timeline found on the FDA website (and I know some EUA’s that have taken months, though only like around 3, which is even shorter than Priority Reviews):


    “FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions.”


    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities


    So does anyone know timeline/deadline for FDA’s EUA’s—or at least within what period most EUA’s fall into (before 3 months, before 2 months, etc.)?
     

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