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US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization

 
• By Sue Sutter

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.

Sunset
The sun will start setting on the FDA's rare pediatric disease PRV program on 30 September. • Source: Shutterstock

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.

The FDA has been dealing with an influx of requests for rare pediatric disease designation with the program’s sunset provisions kicking in on 1 October and has cautioned

Key Takeaways

  • Products that do not receive rare pediatric disease designation by 30 September will not be eligible for a priority review voucher unless the program is extended or reauthorized by Congress.

  • The looming sunset has led to a spike in designation requests, although the FDA says it may not be able to review all of them within the 60-day response timeframe

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