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

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

FDA is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief.”  This draft guidance is a revision of the guidance for industry entitled “User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR,” issued February 2007.   The draft guidance describes the circumstances under which certain applications for fixed-combination and single-entity versions of previously approved antiretroviral therapies for the treatment of HIV under the President’s Emergency Plan for AIDS Relief (PEPFAR) may be eligible for a barrier-to-innovation waiver.

Draft Guidance Document

Federal Register Notice