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# Guide on User Fee Waivers for HIV Drugs
- URL: https://www.fdaweb.com/guide-on-user-fee-waivers-for-hiv-drugs/
- Published: 2023-08-03T12:00:00.000Z
- Updated: 2026-09-14T18:48:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155016

*Federal Register* notice: FDA is making available a draft guidance entitled “PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR.” The draft guidance describes circumstances under which an applicant may be eligible for a “barrier-to-innovation” waiver under the Prescription Drug User Fee Act for certain NDAs for single-entity antiretroviral (ARV) and fixed-combination ARV drug products for treating or preventing human immunodeficiency virus 1\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-03/pdf/2023-16560.pdf?ref=fdaweb.com).