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GUIDANCE DOCUMENT

PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR August 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1635
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under the Prescription Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for single-entity (SE) antiretroviral (ARV) and fixed-combination (FC) ARV drug products for the treatment or prevention of human immunodeficiency virus-1 (HIV-1 or HIV). 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1635.

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