
FDA PreCheck pilot aims to speed up U.S. drug manufacturing approvals
The FDA has chosen seven companies, including Eli Lilly and Regeneron, to join a PreCheck pilot that lets regulators begin reviewing new manufacturing facilities while they’re under construction, with the goal of catching issues early and potentially shaving up to 14 months from timelines. The program comprises facility readiness guidance and an expedited application submission/inspection process, and targets drugs produced domestically—especially biologics and gene therapies.













