Rare Pediatric Priority Review Voucher Program Seems Headed For Short-Term Renewal

Chair of the House Energy and Commerce Committee raises questions about the priority review voucher program’s value, suggesting another limited extension may be upcoming.

Priority Review Voucher
An advocate for the PRV program said rare pediatric disease designations and approvals have increased since it launched.

Reauthorization of the rare pediatric disease priority review voucher program does not appear threatened by the House Energy and Commerce Committee, but the fact that questions about its value continue to emerge may be telling about its long-term future.

A 29 July legislative hearing on HR 4439, the Creating Hope Reauthorization Act, which would ensure the voucher opportunity...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Rare Diseases

More from Pink Sheet

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By 

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By 

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.