The U.S. Food and Drug Administration selected seven companies Monday — including Eli Lilly $LLY and Regeneron $REGN Pharmaceuticals — for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities.
The FDA estimates the PreCheck program could save participating companies up to 14 months by reviewing facilities while they are still under construction
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The U.S. Food and Drug Administration selected seven companies Monday — including Eli Lilly $LLY and Regeneron $REGN Pharmaceuticals — for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities.
The other participants are 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, according to CNBC.
The FDA launched the PreCheck Pilot Program on Feb. 1, 2026, following an executive order signed by President Donald Trump in May 2025. The agency received more than 80 requests to participate between Feb. 1 and March 1. Eligibility required companies to put forward 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, with coverage under the program limited to products whose approval depends on that facility.
The program operates in two phases. During the first phase, companies receive technical input from the FDA ahead of the site going live, with agency staff weighing in on facility information submitted through a Drug Master File. Once a company moves into the second phase, it gains access to pre-submission meetings with regulators, faster facility assessments, and inspections conducted earlier than would otherwise occur in the standard review timeline.
The selected facilities span a range of drug types and locations. At Eli Lilly's Lebanon, Indiana location, the focus will be on producing active pharmaceutical ingredients for both current and pipeline medicines — among them the core compounds used in the company's GLP-1 weight-loss treatments, according to the outlet. Out of Saratoga Springs, New York, Regeneron's new site is slated to turn out biologic drug substance, protein therapeutics, and sterile injectable products aimed at treating a range of diseases. Amneal's New York facility is designed to produce sterile liquid small molecule drugs serving patients with pain, respiratory, and eye-related conditions. North Carolina claims three of the seven selected sites: FUJIFILM's plant, which will produce monoclonal antibodies; Kriya Therapeutics' facility, oriented toward adeno-associated virus gene therapies for chronic conditions; and Kyowa Kirin's operation, which will supply biologics for patients with rare diseases. Rounding out the group, Cellares will use its Bridgewater, New Jersey location to manufacture cell-based gene therapies targeting cancer and blood disorders.
"We're pleased to see programs like the FDA's PreCheck Pilot Program that encourage collaboration between innovators and regulators to build next generation manufacturing capabilities and strengthen America's biopharmaceutical industry," Regeneron CEO Leonard Schleifer said in a statement.
The FDA's effort to accelerate domestic drug development extends beyond manufacturing. The agency has separately announced measures to shorten the timeline from drug identification to first-in-human trials and revised guidance to streamline early-stage submissions, as part of a broader push to keep the U.S. competitive in pharmaceutical development.
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