The U.S. Food and Drug Administration opened submissions for its PreCheck pilot program, inviting drugmakers to participate in a pathway designed to accelerate domestic prescription drug manufacturing. The program offers a pre‑inspection and readiness review intended to reduce timelines for factory construction and regulatory acceptance, according to the agency notice. Companies planning to reshore or expand manufacturing capacity can use PreCheck to de‑risk regulatory inspection timelines and help secure faster FDA clearance for new facilities. For supply‑chain officers and CDMOs, the program creates structured opportunities to align capital projects with regulatory expectations and could influence site selection decisions.