WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.
The FDA had launched the PreCheck Pilot Program on February 1 in response to Executive Order 14293 signed by President Donald Trump in May 2025 and following a public meeting on challenges and opportunities to facilitate domestic manufacturing.
The pilot program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market, helping support greater access to critical medicines for Americans.
'The FDA's PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the United States, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines,' said HHS Secretary Robert F. Kennedy Jr. 'This is another important step toward making America healthier, stronger, and more self-reliant.'
FDA said it received more than 80 requests to participate in the FDA PreCheck Pilot Program. To be eligible, companies proposed a new domestic manufacturing facility that will be capable of manufacturing drug products to address a market supply need or improve patient access to therapies for unmet medical needs. Eligible companies also committed to submitting a New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), or a supplement to one of those applications that relies on the new manufacturing facility.
Seven companies have been selected to participate in the pilot.
Amneal Pharmaceutical's facility in Long Island, New York, will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases.
Cellares Corp's facility in Bridgewater, NJ, will manufacture cell-based gene therapy products for oncology and hematology diseases.
Eli Lilly and Company's facility in Lebanon, IN, will manufacture drug substance (active pharmaceutical ingredients) in support of the company's existing and future medicines.
FUJIFILM Biotechnologies' facility in Holly Springs, NC, will support commercial-scale cell culture biomanufacturing.
Kriya Therapeutics' facility in Durham, NC, will manufacture AAV-based gene therapy products to address chronic disease conditions.
Kyowa Kirin's facility in Sanford, NC, will manufacture biotechnology drug substance for rare diseases.
Regeneron Pharmaceuticals' facility in Saratoga Springs, NY, will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.
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