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# PDUFA User Fee Waiver Guidance
- URL: https://www.fdaweb.com/pdufa-user-fee-waiver-guidance/
- Published: 2019-10-16T12:00:00.000Z
- Updated: 2026-09-15T01:57:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145262

FDA has issued a guidance, *Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products*, with recommendations to applicants about requests for waivers, refunds, and reductions of user fees for drugs and biological products. The [document](ttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/prescription-drug-user-fee-act-waivers-reductions-and-refunds-drug-and-biological-products-guidance) revises a 9/2011 guidance. The agency says the revised guidance describes **(1)** the types of waivers, refunds, and reductions available under the user fee provisions of the Federal Food, Drug, and Cosmetic Act; **(2)** the procedures for requesting waivers, refunds, or reductions; and **(3)** the process for requesting a reconsideration or appeal of an FDA decision. It also clarifies related issues such as user fee exemptions for orphan drugs.