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# Guide on Antiretrovirals for HIV–1 Under PEPFAR
- URL: https://www.fdaweb.com/guide-on-antiretrovirals-for-hiv-1-under-pepfar/
- Published: 2023-08-03T12:00:00.000Z
- Updated: 2026-09-14T18:48:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155017

*Federal Register* notice: FDA is making available a draft guidance entitled “Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV–1 Under PEPFAR.” The document addresses versions of antiretroviral (ARV) drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of safety and efficacy of the specific drug product or combination drug product already exists. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-03/pdf/2023-16557.pdf?ref=fdaweb.com).