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# PDUFA Waiver, Reduction, Refund Guidance
- URL: https://www.fdaweb.com/pdufa-waiver-reduction-refund-guidance/
- Published: 2018-06-20T12:00:00.000Z
- Updated: 2026-09-15T00:14:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141730

FDA says it is issuing a draft guidance, *Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products*, with recommendations to applicants planning to request a waiver or reduction in user fees. A *Federal Register* 6/21 [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-13295.pdf?ref=fdaweb.com) says the draft revises a 9/2011 guidance.

According to the agency, the revised draft describes the types of waivers, reductions, and refunds permitted under the user fee provisions and the procedures for submitting requests for waivers, reductions, refunds, and requests for reconsiderations or appeals. The revised draft also is said to provide additional clarification on certain issues such as user fee exemptions for orphan drugs and the agency’s current thinking on considerations relevant to eligibility for user fee waivers, reductions, and refunds.