- Docket Number:
- 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.
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:
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.