The U.S. Food and Drug Administration launched its PreCheck pilot program, accepting applications from biopharma companies seeking to relocate or build prescription drug manufacturing facilities in the U.S. The initiative aims to streamline regulatory review and reduce construction and validation timelines for domestic manufacturing sites, supporting supply‑chain resilience and reshoring efforts. Participation could shorten facility readiness timelines, affect site selection decisions, and create a pathway for companies to align facility design with FDA expectations earlier in the build process.