CNPV
July 22, 2025
FDA accepting applications for the Commissioner’s National Priority Voucher pilot program
The U.S. Food and Drug Administration has officially opened applications for its new Commissioner’s National Priority Voucher (CNPV) pilot programme, aimed at accelerating review timelines for therapies aligned with U.S. national health priorities.
Application requirements:
- Only one application per company
- Applications capped at 350 words
- Only 5 vouchers will be awarded in 2025
- Reviews will be led by a committee chaired by Dr. Vinay Prasad in his role as Chief Medical and Scientific Officer
U.S. national health priorities focused on within this program:
- Public health crisis response: Products addressing urgent/emerging threats or significant population impact.
- Innovative breakthrough therapies: Transformative treatments with novel mechanisms that fundamentally change disease management.
- Large unmet medical needs: Therapies for conditions where existing treatments inadequately address patient outcomes.
- Onshoring and supply chain resilience: Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security.
- Affordability: Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.
The programme is part of the FDA’s broader push to create faster and more flexible regulatory pathways.
