Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief; Draft Guidance for Industry; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief." This draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver for some new drug applications (NDAs) for fixed-combination versions and single- entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).