Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan
FDA will have a total of 12 months to review 351(k) applications and additional time to schedule certain product development meetings under the Biosimilar User Fee Act II agreement; measures to enhance management of user fee resources and improve hiring will carry over from PDUFA VI.
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US FDA's Patrick Frey Joins List Of Agency Leadership Departures
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