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Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities

CNBC · Jun 29, 2026, 6:53 PM

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  • Eli Lilly and Regeneron are among the first seven companies the U.S.
  • The initiative will allow regulators to start reviewing new manufacturing facilities while they're under construction to catch and correct any issues, which the FDA estimates could save companies up to 14 months.

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Eli Lilly and Regeneron are among the first seven companies the U.S. Food and Drug Administration selected for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities, CNBC has learned.

Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies that will participate in the FDA's PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The initiative will allow regulators to start reviewing new manufacturing facilities while they're under construction to catch and correct any issues, which the FDA estimates could save companies up to 14 months.

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