FDA Draft Guide Tackles User Fee Goal To Speed Generic Drug Reviews

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs. Under the draft guide, applicants submitting a pre-submission facility correspondence (PFC) containing manufacturing and bioequivalence facility information may be...