GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the Generic Drug User Fee Amendments (GDUFA) III program features a number of enhancements agreed upon by the Agency and industry, as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). These enhancements include a mechanism to enable assessment of DMFs in advance of certain ANDA and prior approval supplement (PAS) submissions.

Pursuant to commitments under GDUFA III, FDA issued a draft guidance for industry entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.” This guidance describes the process outlined in the GDUFA III commitment letter in greater detail and provides recommendations to DMF holders on how to provide the relevant information to FDA. Specifically, this 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 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request.

Additionally, FDA will be hosting a Small Business Industry Assistance (SBIA) DMF workshop, “GDUFA III Enhancements and Structured Data Submissions,” on November 30, 2022.  For more information and to register for this workshop, please visit SBIA’s website.