FDA BRIEF: Week of Oct 3, 2016

fda guidances


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


  • 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


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