This program grants a voucher for priority review from the US Food and Drug Administration (FDA), which aim to render a decision within 6 months (in contrast to 10 for a standard review). The developed drug for which the voucher is awarded must be intended for a rare disease or condition and that primarily affect individuals from 0 to 18 years. The voucher can be utilized for any other drug development program.
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Rare Pediatric Priority Review Voucher
Published by IRDiRC
Paediatric MedicineResearch and Drug DevelopmentRegulatory AffairsMarketing AuthorisationOrphan MedicineRegulatory AdviceRare Paediatric Priority Voucher