Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product at wooden high chair. On December 27, 2020, the Rare Pediatric Disease Priority Review Voucher Program was extended. This voucher is transferable and allows the owner to use the voucher to redeem the priority review of any drug marketing application. For details, please check FDA guidance:
