The FDA introduced the Commissioner’s National Priority Voucher (CNPV) program to expedite drug reviews to one or two months for products addressing U.S. national health priorities. Eligibility is determined by the FDA Commissioner based on contributions toward public health crises, innovation, and domestic manufacturing. The pilot program requires early submission of chemistry, manufacturing, and control data and draft labeling to facilitate a streamlined, multidisciplinary review process. The initiative is part of FDA Commissioner Marty Makary’s vision to modernize regulatory pathways and reduce unnecessary delays without compromising scientific rigor.