FDA PreCheck pilot aims to speed up U.S. drug manufacturing approvals
TL;DR Summary
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.
- Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities CNBC
- Lilly, Regeneron selected for US program to review new manufacturing facilities faster, CNBC reports Yahoo
- Eli Lilly (LLY) Joins FDA PreCheck Pilot Program for Manufacturi GuruFocus
- Eli Lilly, Regeneron among first selections for FDA PreCheck program, CNBC says TipRanks
- FDA selects Lilly, Regeneron for program to speed up review of new manufacturing facilities, CNBC reports WTVB
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