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FDA’s PreCheck Speeds Drug Plant Builds | Business and Finance News
Description
The FDA just launched PreCheck, a bold new pilot program to slash drug manufacturing timelines by getting regulators involved during construction—not after. Seven major companies, including Eli Lilly, Regeneron, and Amneal, are leading the charge, with facilities spanning weight-loss drugs, biologics, gene therapies, and rare disease treatments. By offering early technical reviews, pre-submission meetings, and faster inspections, the FDA aims to shave up to 14 months off the process. This isn’t just about speed—it’s a strategic push to keep the U.S. at the cutting edge of biopharma, fostering collaboration and building next-gen manufacturing capabilities right here at home.
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