Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals Under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability

Résumé

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single- Entity Versions of Previously Approved Antiretrovirals under PEPFAR." The draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver under the Prescription Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for single-entity (SE) antiretroviral (ARV) and fixed-combination (FC) ARV drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1). The draft guidance is also intended to help applicants request a barrier-to-innovation waiver under those circumstances.