Priority Review Vouchers


Eligibility


To be eligible for a voucher, the drug or vaccine must satisfy the following criteria.

  • Treat one of the following diseases:
  • Contain no active ingredient (including any ester or salt of the active ingredient) that has been approved in any other FDA application.
  • Offer major advances in treatment, or provide treatment where no adequate therapy exists, thus earning priority review on its own merit. In other words, to win a bonus priority review, the treatment must first get its own priority review.
  • See "Extension to Rare Pediatric" for eligibility for a pediatric voucher.


    This web page is maintained by David Ridley, one of the authors of the priority review voucher program.