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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.

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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.

Requests for RPD designation jumped 854%, to 222, in the first seven months of 2020 compared to the same time period in 2019, Janet Maynard, director of the Office...

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