FDA selects Eli Lilly, Regeneron, and five others for PreCheck pilot to speed manufacturing facility reviews
By
Angelica Peebles
Summary
The FDA has selected Eli Lilly, Regeneron, and five other pharmaceutical companies for its PreCheck pilot program, which allows regulators to begin reviewing new domestic manufacturing facilities while they are still under construction. This initiative aims to accelerate the review process by catching and correcting issues early, potentially speeding up the availability of new drug manufacturing capacity in the U.S.
Source
bskyFDA selects Eli Lilly, Regeneron, and five others for PreCheck pilot to speed manufacturing facility reviewscnbc.comKey quotes
· 2 pulledLilly, 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
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