Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.