Description
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) 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-1 (HIV-1 or HIV).
Scope & Applicability
Product Classes
3Antiretroviral drugs for the treatment or prevention of HIV.
Single-entity versions of previously approved antiretrovirals
Two or more antiretroviral drugs combined in a single dosage form
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
2Annual fee assessed to applicants of approved drugs.
Status of ARV drug products eligible for PEPFAR procurement
Related CFR Sections (3)
- 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.
(a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
See Also (8)
- Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Development of a Shared System REMS Guidance for Industry (Status: Draft)
- Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 : Guidance for Industry (Status: Final)
- Orange Book Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
- REMS Document Technical Conformance Guide (Status: Final)
- Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry (Status: Draft)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)