### Question
How does FEDERAL FOOD, DRUG, AND COSMETIC ACT define priority review voucher?


### Answer
Under *21 U.S.C. § 360ff*, **priority review voucher** is defined as:

> 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

#### Citation:
  - *21 U.S.C. § 360ff*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part B-Drugs for Rare Diseases or Conditions**

