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# Early Reviews of Drug Master Files Cited in ANDAs
- URL: https://www.fdaweb.com/early-reviews-of-drug-master-files-cited-in-andas/
- Published: 2022-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:01:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152878

FDA has posted a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/review-drug-master-files-advance-certain-anda-submissions-under-gdufa?ref=fdaweb.com) entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA” that introduces an enhancement under the reauthorized generic drug user fee program that became effective 10/1.

The document is intended for holders of Type 2 active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an ANDA or a prior-approval supplement (PAS) to an ANDA. It describes instances when an early assessment,or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which the agency would commence an early assessment of such DMFs six months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request.