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Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding Ban

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Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39).

More On These Topics From The Pink Sheet

US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization

Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal

Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding Ban
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Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding Ban
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