Description
This guidance provides information on the implementation of section 1102 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which added section 524 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360n).2 Section 524 authorizes the FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified in that section. Since the enactment of FDAAA, we have received numerous inquiries about the scope of section 524 and how various aspects of section 524 should be interpreted. The purpose of this guidance is to provide a response to those questions.
Scope & Applicability
Product Classes
4Product eligible for priority review voucher
Two or more active ingredients combined at a fixed dosage
A drug intended for use in a rare disease or condition
Drug or biological product for prevention or treatment of tropical diseases; Drug products intended for prevention or treatment of tropical diseases
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1Extra fee required when using a voucher; Fee required when using a priority review voucher
See Also (8)
- Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (Status: Final)
- Prussian Blue Drug Products — Submitting a New Drug Application (Status: Final)
- Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (Status: Final)
- Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (Status: Final)
- Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff (Status: Final)
- Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry (Status: Draft)
- Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry: Guidance for Industry (Status: Final)
- Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry (Status: Final)