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# Guide on ANDA Drug Master File Reviews
- URL: https://www.fdaweb.com/guide-on-anda-drug-master-file-reviews/
- Published: 2024-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:44:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158011

FDA has posted a [guidance](https://www.fda.gov/media/162019/download?ref=fdaweb.com) entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.” The document is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an ANDA. It explains how FDA is using a program enhancement agreed to as part of the Generic Drug User Fee Amendments negotiations.

Specifically, the guidance describes instances when an early assessment, or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs six months prior to an ANDA or prior approval supplement submission referencing the DMF. It also provides recommendations for such DMF holders when making a request.