FDA Schedules Public Meeting on the Commissioner’s National Priority Voucher Pilot Program

As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program.

The agency also announced a public hearing on June 4, to allow stakeholders to present information and views about the program. The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.

The CNPV pilot program was established in June 2025 to address critical public health needs by providing an ultra-fast review pathway for drugs and biological products of strategic national importance while maintaining the FDA’s rigorous scientific and regulatory standards. So far, the agency has awarded vouchers for 18 products and granted four approvals, including two approvals for oncology drugs delivered 44 and 55 days after filing.