White Paper

Commissioner’s National Priority Voucher (CNPV) Pilot Program

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The FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program, launched in June 2025, creates a highly accelerated 1–2 month review pathway for products addressing key national health priorities such as unmet medical needs, domestic manufacturing resiliency, public health threats, healthcare affordability, and advanced therapeutic innovation. Entry into the program may occur through FDA nomination or a brief sponsor- submitted application.

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