health
Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities
Eli Lilly and Regeneron are among the first seven companies the FDA has selected for its PreCheck Pilot Program, CNBC has learned.
TL;DR
- The FDA's PreCheck pilot program aims to accelerate the review of new domestic pharmaceutical manufacturing facilities.
- Seven companies, including Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin, are the initial participants.
- The program could reduce review times by up to 14 months by allowing regulators to assess facilities during construction.
- Eligibility requires new facilities capable of producing drugs that address market supply gaps or unmet medical needs.
- The program includes components for facility readiness guidance and expedited application feedback and inspections.
- Companies are focused on producing biologic drugs and gene therapies, which involve complex manufacturing processes.