FDA Commissioner Martin Makary unveiled a pilot Commissioner’s National Priority Voucher (CNPV) program aiming to accelerate drug reviews for medicines addressing U.S. national priorities such as health crises and unmet medical needs. The approach promises streamlined submissions, enabling companies to submit manufacturing and prescribing information ahead of final clinical results, targeting review times of one to two months post-final data. Makary emphasized eliminating unnecessary regulatory steps and leveraging artificial intelligence to improve review efficiency. This initiative seeks to bolster U.S. biotech leadership amid increasing global competition by expediting innovative therapies’ market access.