GUIDANCE DOCUMENT
PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR August 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2018-D-1635
- Docket Number:
- FDA-2018-D-1635
- Issued by:
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Guidance Issuing OfficeCenter 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).