priority review voucher

(2)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 underor section 351(a) of the Public Health Service Act [] after the date of approval of the rare pediatric disease product application.


21 USC § 360ff(a)(2)

Scoping language

In this section
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