FDA selects seven companies for accelerated manufacturing review pilot

• The U.S. FDA selected seven companies, including Eli Lilly and Regeneron Pharmaceuticals, for its PreCheck Pilot Program to speed up reviews of new domestic pharmaceutical manufacturing facilities.
• The program allows regulators to evaluate sites during construction, potentially saving companies up to 14 months in the approval process.
• Selected facilities will produce a range of products, including GLP-1 ingredients, biologics, gene therapies, and monoclonal antibodies across multiple states.

The U.S. Food and Drug Administration selected seven companies for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities.

The participants include Eli Lilly (NYSE:LLY), Regeneron Pharmaceuticals, Amneal Pharmaceuticals, Cellares Corp., FUJIFILM Biotechnologies, Kriya Therapeutics, and Kyowa Kirin.

Rather than waiting until a facility is complete, the program gives regulators the ability to evaluate sites during the construction phase, identifying and addressing problems early enough to avoid downstream delays in drug approvals.

The FDA estimates the approach could save companies up to 14 months.

The PreCheck Pilot Program was launched on February 1, 2026, following an executive order signed by President Donald Trump in May 2025.

The agency received more than 80 requests to participate, with eligibility requiring companies to propose a new U.S. facility whose output would fill a gap in the drug supply or expand patient access to treatments in areas of unmet medical need.

The selected facilities span various drug types and locations, including Eli Lilly’s site in Lebanon, Indiana focused on active pharmaceutical ingredients for GLP-1 weight-loss treatments.