Federal Register :: Public Inspection: Guidance: Rare Pediatric Disease Pediatric Priority Review Vouchers

Federal Register :: Public Inspection: Guidance: Rare Pediatric Disease Pediatric Priority Review Vouchers

FDA In Brief: FDA updates draft guidance on rare pediatric disease priority review voucher program

The U.S. Food and Drug Administration today issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry. The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease as one that is a rare disease and one where the disease is ...

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