Actions intended to improve the efficiency of the generic drug development, review, and approval process

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On January 10, 2024, FDA revised the draft guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” This draft guidance, last published in October 2017, provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.

This revision reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) and clarifies what matters are appropriate for requests for reconsideration.

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