# PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/pdufa-waivers-reductions-and-refunds-for-fixed-combinations-and-single-entity-versions-of-previously-approved-antiretrovirals-under-pepfar/6d0b93d6-4d11-41b1-815d-d6970112dcdd

> FDA guidance document: PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR. Issue date: August 03, 2023. Get complete insights and analysis.

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## Details

- Title: PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-08-03
- Comment Close Date: 2023-10-02
- Last Changed: 2023-08-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1635">FDA-2018-D-1635</a>

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