Guidances: Tropical Diseases Voucher
FDA BRIEF: Week of Oct 3, 2016
FDAAA (Food and Drug Administration Amendments Act of 2007), SECTION 524
- Priority review vouchers to sponsors of certain tropical disease product applications
- Further explanation of Section 524 c
POLICIES AND PROCEDURES
- Definitions: Tropical Disease Product Application and Tropical Disease
- Priority Review Vouchers: General Information
- Priority Review Vouchers: Eligibility
- Priority Review Vouchers: Transferability
- Priority Review Voucher Fees and Use
- Relationship Among the Priority Review Voucher Program and Other Programs