Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Requests for Reconsideration at the Division Level Under GDUFA.'' This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and 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 guidance also provides information for applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the Agency's process for responding to those requests.