The U.S. Food and Drug Administration opened submissions for its PreCheck pilot program, inviting drugmakers to apply for a streamlined review pathway aimed at accelerating domestic prescription‑drug manufacturing. The pilot targets facilities that align with 'national priorities' and seeks to reduce barriers for companies reshoring drug production to the United States. Regulators said the program will prioritize site inspections and manufacturing readiness reviews to compress timelines for facility qualification. Industry observers expect the program to play a role in onshoring strategies and to influence partners, contract manufacturers and supply‑chain planning across the industry. Why it matters: Faster factory approvals change the calculus for capacity investments and could shorten timelines for bringing critical medicines and biosimilars to U.S. patients while reducing dependence on foreign manufacturing.