Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing related to the Commissioner's National Priority Voucher (CNPV) Pilot Program, which is designed to significantly reduce review times for qualifying new drug applications (NDAs), biologics license applications (BLAs), and manufacturing or efficacy supplements through enhanced regulatory engagement and streamlined review procedures. The CNPV Pilot Program is intended to expedite approvals for products that align with critical U.S. national health priorities while maintaining FDA's rigorous scientific and regulatory standards. We are holding this public hearing to obtain feedback and perspectives regarding the CNPV Pilot Program, including feedback on the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.