The FDA launched its PreCheck Pilot Program to strengthen domestic pharmaceutical manufacturing capacity by moving regulator engagement earlier into facility design and construction. Under the two-phase model, participating companies receive early technical guidance and later streamlined inspections during formal review, without any guarantee of expedited approvals. The FDA selected a cohort of seven companies from more than 80 applications. The group includes Eli Lilly, Cellares, Fujifilm, Regeneron, Kyowa Kirin, and Kriya Therapeutics, with participation designed to generate operational learnings before expanding the approach. The program is framed as part of a broader U.S. push to onshore drug production amid persistent shortages and rising consumer pricing pressures, and it is intended to help facilities be “application-ready” when submissions occur.