On January 10, 2024, FDA revised the draft guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” This draft guidance, last published in October 2017, provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a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.
During the assessment of an ANDA, FDA considers important issues that are central to product evaluation. Sometimes, an applicant may disagree with FDA, and because these disagreements often involve intricate matters, the agency has procedures in place to ensure open and prompt consideration of an applicant’s concern(s). The procedures and policies described in this guidance are intended to formalize FDA’s current and historical practices and to continue to promote rapid and fair resolution of eligible requests between an applicant and FDA. Requests within the scope of this guidance document should concern certain actions that relate to an ANDA and have scientific significance.
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.
Takeaway: FDA issued this guidance as part of the agency’s GDUFA III commitments and as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process. An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines.
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