FDA guidance for reconsideration at the division level under GDUFA

The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.”

This guidance, which finalizes the draft guidance published in January 2024, provides recommendations on the procedures for abbreviated new drug application (ANDA) applicants that wish to pursue a request for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, the FDA considers important issues that are central to product evaluation. Sometimes an applicant may disagree with the 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).