US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse

 
• By Sarah Karlin-Smith

The agency’s actions may signal its optimism about near-term reauthorization despite the PRV program and other bills aimed at tackling rare and childhood diseases not making the December 2024 government spending bill.

one lone Zebra standing in a field.
The FDA told the Pink Sheet that it continues granting rare pediatric disease designations, even though those issued after 20 December 2024 will not qualify a product for a priority review voucher. (Shutterstock)

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