FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit

 
• By Sarah Karlin-Smith
  
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As the reauthorization deadline nears, CDER and CBER leaders stressed that sunsetting the program would hurt pediatric rare disease development, while endorsing a new Democrat-proposed stick for rare disease research. 

older female doctor talks to young child and parent
FDA leaders have a new message on the value of the rare pediatric PRV program with the reauthorization deadline nearing. • Source: Shutterstock

US Food and Drug Administration leadership recently stressed the importance of the rare pediatric disease priority review voucher program, a notable shift for the agency, which once said the program had adversely impacted its ability to set public health priorities and manage its workload, just as the program heads toward its reauthorization deadline.

Key Takeaways

  • The CDER and CBER directors said the rare pediatric disease priority review voucher is an important incentive, a notable shift for an agency that once wanted to scrap the program.

Center for Biologics Evaluation and Research Director Peter Marks and Center for Drug Evaluation and Research Director Patrizia Cavazzoni stressed...

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