Pharmaceutical Executive November 7, 2025
Key Takeaways
- The CNPV program now includes 15 therapies, focusing on critical public health and national security priorities like obesity, cancer, and drug-resistant tuberculosis.
- Accelerated review timelines reduce the traditional 10-12 month process to one to two months, expediting market access for high-impact treatments.
- Eligibility criteria emphasize U.S. manufacturing, affordability, and addressing unmet health needs, with a multidisciplinary review model for expedited decision-making.
- The program allows submission of most application components before clinical trial completion, aiming to reduce inefficiencies and bring treatments to market faster.
The FDA has added six new therapies to its Commissioner’s National Priority Voucher program, bringing the total to 15 products that address major public health needs, including obesity, cancer, sickle cell disease, and...
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