The FDA launched the first wave of its PreCheck Pilot Program for onshoring and improved regulatory predictability in drug manufacturing. The agency selected seven biopharma manufacturers, including Eli Lilly and Regeneron, and named Cellares and Fujifilm among the participants. The pilot is intended to streamline FDA plant assessments ahead of specific product applications and to help firms prepare manufacturing sites for regulated filings with earlier feedback. The program follows FDA efforts to encourage biopharma manufacturing expansion in the U.S., aiming to reduce uncertainty around compliance timelines. Separately, the FDA said a “first flight” of the pilot manufacturing framework is now moving forward, signaling early operational roll-out rather than planning-only engagement.