Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products." This revised draft guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This draft guidance is a revision of the guidance for industry entitled "User Fee Waivers, Reductions, and Refunds for Drug and Biological Products," issued in September 2011.