Drugs

FDA Selects 7 PreCheck Pilot Participants

FDA has selected seven companies to participate in the FDA PreCheck Pilot Program, an initiative it says is intended to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain. An agency statement says the pilot was launched 2/1 in response to an Executive Order issued by President Donald J. Trump to promote domestic production of critical medicines.

“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 statement says.

FDA says it received over 80 requests to participate in the pilot. To be eligible, companies proposed a new domestic manufacturing facility that would 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 NDA, BLA, ANDA, or a supplement to one of those applications that relies on the new manufacturing facility.

The statement says the selected companies are:

Amneal Pharmaceutical – facility in Long Island, NY, to manufacture small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases;
Cellares Corp. – facility in Bridgewater, NJ, to manufacture cell-based gene therapy products for oncology and hematology diseases;
Eli Lilly – facility in Lebanon, IN, to manufacture active pharmaceutical ingredients to support the company’s existing and future medicines;
FUJIFILM Biotechnologies – facility in Holly Springs, NC, to support commercial-scale cell culture biomanufacturing;
Kriya Therapeutics – facility in Durham, NC, to manufacture AAV-based gene therapy products to address chronic disease conditions;
Kyowa Kirin – facility in Sanford, NC, to manufacture biotechnology drug substance for rare diseases; and
Regeneron Pharmaceuticals – facility in Saratoga Springs, NY, to manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.

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