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  1. Generic Drug User Fee Amendments

GDUFA II Drug Master File (DMF) Review Enhancements

Effective communication between ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals.  GDUFA II features new and enhanced mechanisms to facilitate this communication, including first adequate letters to indicate a DMF has no open issues related to the review of a referencing ANDA, no further comment letters, and expanded opportunities for DMF holders to request teleconferences with FDA regarding first cycle DMF deficiency letters.  The GDUFA II commitment letter provides additional information about the DMF review enhancements.

Pursuant to commitments under GDUFA II, FDA issued a draft guidance on post-approval changes to a Type II API DMF and submission mechanisms for ANDA applications who reference a Type II API DMF.  FDA also issued a revised draft guidance, Completeness Assessments for Type II API DMFs under GDUFA.

FDA also issued a revised draft guidance, Completeness Assessments for Type II API DMFs under GDUFA.

Type II Drug Master Files (DMF) Update

This presentation covers changes and new features related to Type II DMFs for Active Pharmaceutical Ingredients (API).

 
 

Transcript | Slides (PDF - 126 KB)

 

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