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Rare Pediatric Disease Designation Requests Skyrocket Ahead Of Voucher Program’s Sunset

 
• By Sue Sutter

US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.

A rising hot-air balloon while others are still on the ground, competition concept. leading. leadership. Concept of The First Place. First balloon rising above others.
The number of requests for rare pediatric disease designation rose sky high in July. • Source: Shutterstock

The US Food and Drug Administration is seeing a record number of requests for rare pediatric disease designation ahead of the statutory expiration of the priority review voucher program.

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Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
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