Fixed-Combination Antiretroviral Drug Waiver Guidance

FDA has issued a guidance, Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief, to describe circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under PDUFA for some NDAs for fixed-combination and single-entity versions of previously approved antiretroviral therapies for treating HIV. The guidance revises the one issued in 2/2007.

The agency says it 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 will qualify for a waiver under the barrier-to-innovation user fee waiver.

The document includes an Introduction; Background; Basis for Assessing PDUFA User Fees; Fee Waivers and Refunds; Submitting Requests for Waivers, Reductions, and Refunds; FDA Responses to Requests for Waivers and Reductions; and Disclosure of Public Information.