Eli Lilly and Regeneron among first firms in FDA manufacturing review pilot
FDA PreCheck pilot speeds U.S. drug plant reviews for Lilly, Regeneron and more See how early FDA oversight could cut approvals by up to 14 months
Eli Lilly, Regeneron and five other companies have been selected for the FDA’s new PreCheck pilot program, which is designed to speed reviews of pharmaceutical manufacturing facilities in the U.S.
According to the FDA, the program lets regulators begin reviewing a plant while it is still being built, with the goal of identifying problems earlier and shortening the overall approval process by as much as 14 months.
The initial participants include companies developing biologics, gene therapies and other advanced medicines. Lilly’s Indiana site, Regeneron’s New York facility and Fujifilm Biotechnologies’ North Carolina plant are among the projects chosen for the pilot.