Eli Lilly, Regeneron, and five other companies have been selected by the U.S. Food and Drug Administration (FDA) to participate in a pilot program aimed at expediting the review process for new pharmaceutical manufacturing facilities. This initiative, called the PreCheck pilot program, allows regulators to begin evaluations of facilities while they are still under construction, enabling early identification and correction of potential issues. The FDA estimates that this could reduce the time to market for new drugs by up to 14 months.
The selected companies include Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. They represent a mix of established pharmaceutical leaders and biotech firms focusing on complex biologic drugs and gene therapies. To qualify for the PreCheck program, a company must establish a new facility that addresses a supply gap or improves access to critical therapies.
Among the notable sites is Eli Lilly’s facility in Lebanon, Indiana, which will produce active ingredients for GLP-1 medications. Regeneron is set to develop a new $2 billion manufacturing site in Saratoga Springs, New York, aimed at bolstering U.S. biologics production. Additionally, Fujifilm’s facility in North Carolina is already operational, manufacturing monoclonal antibodies for various clients.
The PreCheck program features two primary components: facility readiness assessments, where companies receive guidance from the FDA before opening, and a streamlined application process that incorporates real-time feedback and inspections. As the initial batch of participants moves forward, the FDA seeks to enhance domestic pharmaceutical manufacturing capabilities and address public health needs.
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