GUIDANCE DOCUMENT
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief Draft Guidance for Industry June 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2018-D-1635
- Issued by:
-
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)2 for some new drug applications (NDA) for fixed-combination (FC)3 and single-entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).4 FDA 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 (PEPFAR) will qualify for a waiver under the barrier-to-innovation user fee waiver.
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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
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All written comments should be identified with this document's docket number: FDA-2018-D-1635.