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FDA Revises Guidance on DMFs and Prior Approval Supplements to Reflect GDUFA II

 
• By Joanne S. Eglovitch

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.

Colorful office folders

FDA has revised two guidance documents to reflect changes under the Generic Drug User Fee Act II, which took effect Oct. 1. The agency noted in one that it will no longer charge user fees for generic drug manufacturers that submit prior approval supplements. FDA said in the other that it had agreed to meeting certain performance goals in reviewing Type II drug master file completeness assessments to reflect the GDUFA II user fee agreement.

FDA revised the “ANDA Submissions: Prior Approval Supplements Under GDUFA” guidance on Oct. 1 by removing any reference to paying user fees for supplements.

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