FDA Commissioner Martin Makary introduced a pilot program aimed at accelerating the review process for drugs addressing U.S. national interests. The initiative extends the established priority review voucher framework by enabling companies to pre-submit portions of their applications, notably manufacturing and prescribing information, before the completion of pivotal clinical trial data. Selected drugs aligned with governmental priorities, such as addressing health crises, delivering innovative cures, or enhancing domestic drug manufacturing, may obtain review timelines shortened from the typical 10–12 months to as little as 1–2 months post-submission. Although the pilot initially limits the number of vouchers and prohibits transferability, it represents a substantial shift toward regulatory modernization intended to maintain the U.S. biotech sector’s global competitiveness and improve patient access to novel therapies.