The FDA has chosen Eli Lilly and Regeneron to participate in a new pilot program aimed at speeding up the development and approval of domestic drug manufacturing facilities, CNBC reports.
The initiative is designed to modernize how the agency oversees construction and readiness of pharmaceutical production sites by engaging with companies earlier in the process.
Instead of waiting until a manufacturing plant is fully built before conducting detailed regulatory review and inspection, the program allows participating companies to collaborate with the FDA during the design and construction phases.
This early visibility approach is intended to reduce delays, improve compliance planning and make final approvals more efficient once facilities are ready to operate.
Eli Lilly and Regeneron are among the first companies selected, reflecting their significant ongoing investments in expanding U.S.-based production capacity. Both firms are scaling up manufacturing for high-demand therapies, and their participation suggests the program is initially targeting large, established drugmakers with active construction pipelines.
The broader goal of the initiative is to strengthen the resilience of the U.S. pharmaceutical supply chain.
By making it faster and more predictable to build domestic drug production sites, regulators aim to reduce dependence on overseas manufacturing and improve access to critical medicines. The program also reflects growing policy emphasis on reshoring key parts of the healthcare and biotech supply chain.
