The U.S. Food and Drug Administration (FDA) has initiated a pilot program led by Commissioner Martin Makary aimed at streamlining and accelerating the drug review process for medicines addressing national priorities. This novel commissioner’s national priority voucher (CNPV) system promises to reduce review times to one to two months by enabling earlier submission of manufacturing and prescribing data and employing coordinated review teams. Additionally, the FDA has intensified regulatory scrutiny of clinical trials involving shipment of U.S. patient cells to adversarial nations, notably China, halting new trials in this space amidst concerns over genetic engineering and intellectual property security. These moves underscore ongoing FDA efforts to modernize regulatory pathways while ensuring national security and public health interests remain safeguarded.