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GUIDANCE DOCUMENT

Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief Guidance for Industry June 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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)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.


Submit Comments

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.