The U.S. FDA launched its PreCheck Pilot Program, selecting seven companies—including Eli Lilly, Cellares, Fujifilm, Regeneron, Kyowa Kirin, and Kriya Therapeutics—to receive early, facility-focused engagement. Under the two-phase model, participating firms can get technical guidance before sites become operational and then receive streamlined inspection support during formal review. The initiative does not guarantee expedited approvals or favorable inspection outcomes, and it targets new domestic facilities. The program is positioned within broader U.S. onshoring efforts amid drug shortage and price concerns.