Eli Lilly, Regeneron among first companies selected for FDA initiative to speed
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
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.
Producing more drugs domestically has been a priority for the Trump administration. The initial recipients range from the most valuable healthcare company in the world to closely held biotechs developing gene therapies. The majority of them plan to make biologic drugs or genetic medicines, which involve more complex manufacturing than the pills most Americans know best.
To be eligible for the PreCheck program, companies needed to build a new manufacturing facility capable of making drugs that would address a market su
Fuente original: CNBC Top News (https://www.cnbc.com/2026/06/29/eli-lilly-regeneron-in-fda-precheck-manufacturing-program.html)
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