priority review voucher
(2) Priority review voucher The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] after the date of approval of the rare pediatric disease product application.