Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "User Fee Waivers, Reductions, and Refunds for Drug and Biological Products." This guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled "Draft Interim Guidance Document for Waivers of and Reductions in User Fees," issued July 16, 1993.