Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Requests for Reconsideration at the Division Level Under GDUFA." This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within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 This draft guidance revises the draft guidance of the same title issued in October 2017. This revision is being issued to reflect the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) and to clarify what matters are appropriate for requests for reconsideration.
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