The FDA announced the first nine recipients of its Commissioner’s National Priority Voucher (CNPV) pilot program, offering a pathway to regulatory decisions in one to two months. The picks include investigational therapies, previously approved foreign drugs and generics, and span oncology, rare disease and gene therapy candidates. The agency frames the program as a tool to accelerate products that address national priorities such as unmet medical need and domestic manufacturing. Industry groups and developers welcomed the potential speed but flagged operational uncertainty about how the pilot will interact with existing expedited pathways and advisory timelines. For sponsors, the voucher could materially shorten commercialization timelines and valuation inflection points; for competitors it raises questions about process transparency and fairness in selection.