FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections

The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities.

The cohort includes large drugmakers Eli Lilly and Regeneron as well as biotech and technology firms such as Cellares, Fujifilm, Kriya Therapeutics, and Amneal. These participants will work with the agency to test new data‑rich submission formats and risk‑based assessment methods.

The goal of PreCheck is to reduce the time needed for facility inspections and approvals, potentially shortening the path to market for new medicines. The FDA expects the pilot to generate insights that could be applied more broadly across the industry.