Stakeholders brace for bumps in rare pediatric disease PRV reauthorization
A voucher program designed to stimulate drug development for rare pediatric diseases will sunset later this year if lawmakers don’t reauthorize it — and rare disease advocates and experts are bracing for bumps in the road to renewal.
The Rare Pediatric Disease Priority Review Voucher Program allows the FDA to award vouchers to rare disease drug developers who then can use the voucher to receive priority review on a subsequent application or sell it to another developer. The program was first established by Congress in 2012 and has since been reauthorized in four-year increments.
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