FDA Commissioner Marty Makary announced a pilot Commissioner’s National Priority Voucher (CNPV) program aimed at expediting the review of medicines that address U.S. national interests, including health crises and unmet public needs. The program allows pre-submission of manufacturing data to commence earlier review and potentially reduces approval timelines to 1–2 months post final data submission. This initiative expands upon existing priority review vouchers, aligning regulatory efficiency with strategic public health imperatives to maintain U.S. biotechnology leadership and competitiveness.