Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA." The purpose of this draft guidance is to provide information and recommendations on the Generic Drug User Fee Amendments (GDUFA) III program enhancements agreed upon by the Agency and industry in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter), related to the early assessment of certain Type II drug master files (DMFs) 6 months prior to the submission of certain abbreviated new drug applications (ANDAs) or prior approval supplements (PASs). This draft guidance describes the process outlined in the GDUFA III commitment letter in greater detail and provides recommendations to DMF holders on how to provide the relevant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.