FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tues­day is­sued im­me­di­ate­ly ef­fec­tive guid­ance ex­plain­ing how the coro­n­avirus dis­ease pub­lic health emer­gency is im­pact­ing the con­duct of for­mal meet­ings and its re­view of cer­tain user fee-fund­ed ap­pli­ca­tions.

The guid­ance fea­tures 11 ques­tions and an­swers on how the agency in­tends to han­dle dis­rup­tions af­fect­ing meet­ings and goals un­der its user fee pro­grams es­tab­lished by the Pre­scrip­tion Drug User Fee Act (PDU­FA), Biosim­i­lar User Fee Act (BS­U­FA) and the Gener­ic Drug User Fee Amend­ments (GDU­FA).

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