The FDA's PreCheck pilot program includes Eli Lilly, Regeneron, and five other companies, allowing them to receive regulatory feedback while their manufacturing facilities are still under construction. This initiative is expected to save companies up to 14 months in the approval process, aligning with the U.S. government's goal to boost domestic drug production.
Eli Lilly's facility in Indiana, which will produce key ingredients for GLP-1 medications, and Regeneron's $2 billion site in New York, focused on biologics, are among the initial participants. Regeneron CEO Leonard Schleifer expressed support for the program, emphasizing its potential to strengthen the U.S. biopharmaceutical industry.
Other participants include Fujifilm Biotechnologies, Amneal Pharmaceuticals, Cellares, Kriya Therapeutics, and Kyowa Kirin, all of which are set to manufacture complex biologic drugs and therapies. The program's dual components—facility readiness and application submission—are designed to facilitate faster approvals and enhance collaboration between manufacturers and regulators