The U.S. Food and Drug Administration is announcing the final guidance for industry, “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.”

This guidance provides information and recommendations on the Generic Drug User Fee Amendments (GDUFA) III program enhancements 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 associated prior approval supplements (PASs).  This guidance describes the process outlined in the GDUFA III commitment letter in greater detail and provides recommendations to DMF holders on how to give the relevant information to FDA.

This guidance finalizes the draft guidance of the same title issued on October 6, 2022. FDA considered comments received on the draft guidance as the guidance was finalized, and in response, added a footnote to clarify the potential impact of unsolicited amendments submitted after the prior assessment was granted. [FDA]