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# Draft Guidance on Drug User Fee Waivers
- URL: https://www.fdaweb.com/draft-guidance-on-drug-user-fee-waivers/
- Published: 2018-06-21T12:00:00.000Z
- Updated: 2026-09-15T00:15:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141741

*Federal Register* notice: FDA has made available a draft guidance entitled “Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” The document provides recommendations to applicants planning to request such waivers or reduced user fees. It is a revision of the 2011 guidance entitled “User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-21/pdf/2018-13295.pdf?ref=fdaweb.com).