FDA Names Seven Firms for PreCheck Pilot to Grow Domestic Drug Manufacturing

The FDA selected seven companies to participate in its new PreCheck Pilot Program aimed at accelerating the development of domestic drug manufacturing, expanding capacity, and strengthening the U.S. drug supply chain. The two-phase program will offer early technical guidance (Phase 1: Facility Readiness) and enhanced pre-submission engagement (Phase 2) to bring drugs to market faster; participants include Amneal (Long Island, NY), Cellares (Bridgewater, NJ), Eli Lilly (Lebanon, IN), FUJIFILM Biotechnologies (Holly Springs, NC), Kriya Therapeutics (Durham, NC), Kyowa Kirin (Sanford, NC), and Regeneron (Saratoga Springs, NY).