The clock is once again running out on the US Food and Drug Administration’s rare pediatric disease priority review voucher program, and congressional action is needed within the next few weeks to temporarily extend the popular incentive.
US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization
Under current law, drugs or biologics must receive rare pediatric disease designation before 1 October to be eligible for a priority review voucher. The sunset provisions caused a spike in designation requests and a push by pediatric and rare disease advocates for an extension.
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