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# Fixed-Combination Antiretroviral Drug Waiver Guidance
- URL: https://www.fdaweb.com/fixed-combination-antiretroviral-drug-waiver-guidance/
- Published: 2018-06-06T12:00:00.000Z
- Updated: 2026-09-15T00:11:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141613

FDA has issued a guidance, *Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief*, to describe circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under PDUFA for some NDAs for fixed-combination and single-entity versions of previously approved antiretroviral therapies for treating HIV. The [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610019.pdf?ref=fdaweb.com) revises the one issued in 2/2007.

The agency says it expects that most of the applications and post-approval fees for fixed-combination and HIV therapies proposed for use in the President’s Emergency Plan for AIDS Relief will qualify for a waiver under the barrier-to-innovation user fee waiver.

The document includes an Introduction; Background; Basis for Assessing PDUFA User Fees; Fee Waivers and Refunds; Submitting Requests for Waivers, Reductions, and Refunds; FDA Responses to Requests for Waivers and Reductions; and Disclosure of Public Information.