FDA Selects Eli Lilly and Regeneron for Pilot Program to Accelerate Manufacturing Facility Reviews

The FDA selected seven pharmaceutical companies—Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin—for a pilot program to accelerate reviews of new domestic manufacturing facilities. The PreCheck initiative allows regulators to review sites during construction, potentially saving up to 14 months. Facilities span Indiana, New York, North Carolina, and New Jersey, focusing on biologics, gene therapies, and GLP-1 drugs to address supply gaps and unmet medical needs.

FDA PreCheck pilot program

• ▪The U.S. Food and Drug Administration selected seven companies for the PreCheck pilot program to accelerate reviews of new domestic pharmaceutical manufacturing facilities
• ▪The PreCheck pilot program allows regulators to start reviewing new manufacturing facilities while they are under construction to catch and correct issues

Seven participating companies

• ▪Regeneron is participating in the PreCheck pilot program with its Saratoga Springs, New York facility
• ▪Eli Lilly is participating in the PreCheck pilot program with its Lebanon, Indiana facility
• ▪Fujifilm Biotechnologies is participating in the PreCheck pilot program with a facility in Holly Springs, North Carolina
• ▪Cellares is participating in the PreCheck pilot program with a facility in New Jersey

Facility locations by state

• ▪Eli Lilly's Lebanon, Indiana facility is located in Indiana
• ▪Fujifilm Biotechnologies' Holly Springs facility, Kriya Therapeutics' facility, and Kyowa Kirin's facility are located in North Carolina
• ▪Regeneron's Saratoga Springs facility, Amneal's facility, and one other participating facility are located in New York

Manufacturing focus areas

• ▪Cellares' New Jersey facility will manufacture cell-based gene therapies for oncology and hematology diseases
• ▪Kyowa Kirin's North Carolina facility will manufacture biologics for rare diseases
• ▪Amneal's New York facility will make small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases
• ▪Regeneron's Saratoga Springs, New York facility is a $2 billion site announced in fall 2025 that will produce biologic drug substance, sterile injectables and protein therapeutics for multiple diseases
• ▪Kriya Therapeutics' North Carolina facility will manufacture AAV-based gene therapies for chronic diseases
• ▪Fujifilm Biotechnologies' Holly Springs, North Carolina facility opened in 2025 and is already making monoclonal antibodies for customers Regeneron and Johnson & Johnson
• ▪Eli Lilly's Lebanon, Indiana facility will make the main ingredients of GLP-1 pills and shots

Program timeline benefits

• ▪The FDA estimates the PreCheck pilot program could save companies up to 14 months in facility review time
• ▪Eli Lilly is evaluating how PreCheck and related regulatory improvements may impact the Lebanon, Indiana facility's timeline and will continue to work closely with the FDA to support the program's success
• ▪Fujifilm Biotechnologies expects the operational readiness review before the end of 2026 thanks to the expedited process

Regulatory review process

• ▪The PreCheck pilot program allows regulators to start reviewing new manufacturing facilities while they are under construction to catch and correct issues