Survey: Biopharma Impacts of the Commissioner's National Priority Vouchers Program

FDA announced on Nov 06, 2025, the award of its second batch of Commissioner’s National Priority Vouchers (CNPV) pilot program recipients (1). This cohort adds six awardees, bringing the total number of voucher recipients to 15. According to the Nov 6 news release, the agency is committed to accelerating the review of products that address key national priorities. FDA Commissioner Marty Makary, MD, MPH, stated that the agency is "pioneering new ways of bringing these cures and meaningful treatments to the market faster" (1).

These vouchers are highly selective, granted only when the company agrees to increase affordability, domesticate manufacturing (as a national security issue), or address an unmet public health need (1). The core benefit is speed: national priority voucher holders will receive a decision within 2 months, a drastic reduction of the typical review timeline. This accelerated process includes a one-day “tumor board style” meeting, which brings together a multidisciplinary team of physicians and scientists for review. The FDA stated that is authorized to test these innovative regulatory approaches under acts like the 21st Century Cures Act (1).

In light of the pilot programs continued growth and potential impacts on the bio/pharmaceutical industry, we are conducting as survey of industry professionals. This is your critical chance to voice your opinions and professional insights on what the CNPV program means to you, your organization, and the industry as a whole. Participate today and help shape the conversation around innovative regulatory review!

CLICK HERE TO COMPLETE THE SURVEY!

Reference

1. FDA. FDA Awards Second Batch of National Priority Vouchers. Press Release. Nov 6, 2025.