Eli Lilly and Regeneron among 7 companies picked for FDA PreCheck pilot program

The FDA has officially launched its PreCheck pilot program, selecting seven pharmaceutical and biotechnology companies to receive specialized regulatory guidance for new domestic manufacturing facilities. This initiative, stemming from a 2025 executive order to promote U.S. drug production, aims to streamline the establishment of production sites through technical support and pre-submission meetings. By reducing regulatory barriers, the program seeks to accelerate the domestic supply of critical therapies ranging from blockbuster obesity treatments to advanced gene therapies.

The FDA has officially launched its PreCheck pilot program, selecting seven companies to receive specialized regulatory guidance for new domestic manufacturing facilities. This initiative, stemming from a May 2025 executive order to promote U.S. drug production, aims to streamline the establishment of production sites through technical support and pre-submission meetings. The companies selected for the pilot include Amneal Pharmaceutical, Cellares, Eli Lilly, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron Pharmaceuticals. Each participant is assigned one specific facility that will benefit from frequent communication with the agency to lower regulatory barriers.

Major industry players are utilizing the program to support massive infrastructure investments aimed at critical therapeutic areas. Eli Lilly’s participation focuses on its Lebanon, Indiana, site, where the company has committed $4.5 billion to produce active pharmaceutical ingredients (APIs) for its high-demand obesity medicines and future assets. Similarly, Regeneron is including its Saratoga Springs, New York, facility in the pilot; the company is investing $2 billion to double its manufacturing capacity there for biotech drug substances and sterile injectables. Fujifilm Biotechnologies’ site in Holly Springs, North Carolina, is also a key participant, serving as a commercial-scale hub that already has major production agreements with both Regeneron and Johnson & Johnson.

The pilot program covers a wide range of therapeutic modalities across several states, with North Carolina hosting three of the seven selected sites. Beyond Fujifilm, the state includes Kriya Therapeutics’ viral vector gene therapy facility in Durham and Kyowa Kirin’s biotech drug substance plant in Sanford. In New York, Amneal Pharmaceutical’s Long Island facility will focus on small molecule sterile liquids for pain and respiratory care, while New Jersey’s Cellares is the sole participant focused on cell-based gene therapies. While the program is seen as a positive step for domestic production, some companies like Denali Therapeutics were not selected, highlighting the competitive nature of the pilot as firms seek to accelerate the market entry of new treatments like those for Sanfilippo syndrome.