The U.S. Food and Drug Administration launched its PreCheck pilot program and began accepting submissions from pharmaceutical manufacturers seeking alignment on facilities that support national priorities. The program aims to accelerate the construction and qualification of prescription drug manufacturing sites in the U.S. by offering a pathway for regulatory engagement early in facility planning. Separately, the agency announced operational details for the pilot that will assess facility readiness against pre-specified criteria. Agency officials framed PreCheck as part of a broader push to reshore or expand domestic drug production and improve supply-chain resilience. The program is likely to attract CDMOs, large pharma and emerging biotech sponsors building commercial‑scale plants. Industry analysts expect PreCheck to shorten timelines for plant approvals but warned companies must still meet GMP standards and inspection expectations. The FDA’s move coincides with other policy signals encouraging onshore manufacturing investments.