Rare Pediatric Disease Priority Review Voucher Incentive Program : Free Programs, Utilities and Apps12/9/2016 Vouchers, Rare Diseases, and the FDA Reform Act of 2012 rarediseasereport Published Online. Rare pediatric disease priority review voucher incentive program. 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. The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works. Created in 2012 under the Food and Drug Administration Safety and Innovation Act. United Therapeutics Sells Priority- Review Voucher to Abb. Vie for $3. 50 Million United Therapeutics Corp. Food and Drug Administration. The voucher is part of an incentive program established by the FDA to encourage development of drugs for rare pediatric diseases. FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.
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