FDA Revises Guidance on DMFs and Prior Approval Supplements to Reflect GDUFA II
FDA has revised references in guidance to generic drug user fee requirements that changed under GDUFA II on Oct. 1. One guidance document no longer says for generics firms to pay user fees for prior approval supplement reviews. Another gives review goals for drug master file completeness assessments.
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The US Food and Drug Administration has clarified what it expects to see in drug master file (DMF) completeness assessments for active pharmaceutical ingredients (APIs)1.