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00:02The FDA selected Eli Lilly, Regeneron, and five other companies for a pilot program to speed
00:08reviews of new domestic pharmaceutical manufacturing facilities, according to Reuters.
00:13The companies will join the FDA's pre-check pilot program as drug makers pledge billions
00:18to shift more manufacturing to the U.S. The program lets regulators begin reviewing facilities
00:23while they are under construction to identify and correct issues earlier.
00:29Amnial, Solaris, Fujifilm Biotechnologies, Crea Therapeutics, and Kiowa Curin will also
00:36participate. The FDA selected Lilly's Lebanon, Indiana facility, which makes ingredients for
00:42weight loss pills and shots, and Regeneron's Saratoga Springs, New York site. The program
00:48includes early FDA communication on facility design and construction, plus pre-application
00:53meetings and feedback on manufacturing and quality control.
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