priority review voucher
Defined in 3 places of the United States Code.
The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure 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 material threat medical countermeasure application.
Source
- 2016–present21 U.S.C. § 360bbb-4aFood and Drugs · Priority review to encourage treatments for agents that present national security threats · in this section
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.
Source
- 2012–present21 U.S.C. § 360ffFood and Drugs · Priority review to encourage treatments for rare pediatric diseases · in this section
The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a tropical 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 262 of title 42 after the date of approval of the tropical disease product application.
Source
- 2007–present21 U.S.C. § 360NFood and Drugs · Priority review to encourage treatments for tropical diseases · in this section