The U.S. Food and Drug Administration (FDA) has selected Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin as the first participants in its new PreCheck pilot program, according to CNBC. This initiative is designed to accelerate the regulatory review process for new pharmaceutical manufacturing facilities by allowing the FDA to begin inspections and provide technical guidance while facilities are still under construction, potentially saving companies up to 14 months in the approval process [1].
The program aims to boost domestic drug production, a priority for the Trump administration, and focuses on facilities that will address market supply gaps or improve access to therapies for unmet medical needs. Most of the selected companies plan to manufacture biologic drugs or genetic medicines, which require complex production processes [1].
Among the initial recipients, Eli Lilly's Lebanon, Indiana facility, which will produce the main ingredients for GLP-1 pills and injections, was chosen. Lilly stated it is evaluating how participation in PreCheck may impact the facility's timeline and will continue to collaborate with the FDA [1]. Regeneron's $2 billion Saratoga Springs, New York site, announced last fall, was also selected. Regeneron CEO Leonard Schleifer expressed support for the program, highlighting its role in fostering collaboration between innovators and regulators and strengthening the U.S. biopharmaceutical industry [1].
Fujifilm Biotechnologies' new facility in Holly Springs, North Carolina, is another participant. The site, which opened last year, is already producing monoclonal antibodies for Regeneron and Johnson & Johnson and will expand production for additional customers as more sections open in 2027 and 2028. Fujifilm expects to complete the operational readiness review before the end of the year due to the expedited process and anticipates that the program will enable its customers to pursue faster FDA approval pathways [1].
The PreCheck program consists of two main components: facility readiness, which provides technical guidance before site opening, and application submission, which offers hands-on FDA feedback and expedited inspections. Only drugs manufactured at the selected facilities are eligible for the program's benefits [1].
CONCLUSION
The FDA's PreCheck pilot program marks a significant step toward expediting the approval of new drug manufacturing facilities in the U.S., with major industry players like Eli Lilly and Regeneron among the first to benefit. The initiative is expected to reduce regulatory timelines and enhance domestic production capacity, potentially improving access to critical therapies and strengthening the biopharmaceutical supply chain.