The FDA launched its PreCheck Pilot program to engage earlier in the facility readiness process for new domestic pharmaceutical manufacturing, aiming to strengthen U.S. drug supply chains. The agency selected seven companies from more than 80 applications for a two-phase model that provides facility-focused feedback before drug applications are filed. The participating cohort includes Eli Lilly, Cellares, Fujifilm, Regeneron, Kyowa Kirin, and Kriya Therapeutics, among others. Phase I focuses on early technical guidance on facility readiness, while Phase II supports streamlined inspections during formal application review. An FDA spokesperson said the pilot is intentionally limited in size to refine program details before broader rollout, and it does not guarantee expedited approvals or favorable inspection outcomes. The initiative targets new domestic facilities so the FDA can build facility knowledge ahead of review. The program was launched February 1, 2026 under a Trump administration executive order tied to onshoring manufacturing amid ongoing drug shortages and pricing pressure.