FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing

 Today, 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 launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 14293 signed by President 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.

“President Trump is rebuilding America's pharmaceutical manufacturing base because our nation's health and security depend on it,” said HHS Secretary Robert F. Kennedy Jr. “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. This is another important step toward making America healthier, stronger, and more self-reliant.”

Between February 1 and March 1, 2026, the FDA received over 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.

FDA drug and biologic experts evaluated all requests to participate using an objective framework and scoring rubric. In evaluating the requests, the FDA considered several aspects including the products to be manufactured, the stage of facility development, the anticipated timeline for bringing products to the U.S. market, and innovation in facility development and manufacturing operations.

”This milestone reflects the Trump administration's commitment to strengthening domestic pharmaceutical manufacturing capacity, creating American jobs, and driving down drug costs for families. It further highlights the value of early FDA engagement in building a more resilient U.S. drug supply chain and reducing reliance on foreign sources of pharmaceutical production,” said Acting FDA Commissioner Kyle Diamantas, J.D. “By making our regulatory processes and expectations more transparent, we ensure that American pharmaceutical manufacturers remain global leaders while securely providing high-quality treatments to patients right here at home.”

The following companies have been selected to participate in the pilot:

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

Selected participants will engage with FDA under the two-phase PreCheck model. In  Phase 1 (Facility Readiness), participants will receive early technical guidance from the FDA before the facility becomes operational, including reviews of facility information submitted through a facility-specific Drug Master File (DMF). This allows the FDA to assess and help enhance facility readiness before a drug or biologics application is submitted. In  Phase 2 (Application Submission), participants will have opportunities for enhanced engagement with the FDA through facility-focused pre-submission meetings, which are intended to support expedited facility evaluation and enable inspections earlier in the review cycle.

The FDA PreCheck Pilot Program enhances FDA-industry engagement by facilitating earlier interactions to minimize uncertainty associated with manufacturing readiness. The PreCheck model enables FDA expertise and feedback to inform the acceleration of the facility development process from the outset, while allowing the FDA to identify potential facility issues before they result in deficiencies that could delay or prevent application approval. By facilitating earlier resolution of manufacturing issues, the program is intended to support the timely availability of critical drugs for Americans.

FDA will continue to evaluate implementation of the PreCheck Pilot Program and assess opportunities to inform future program development.

For more information visit the FDA PreCheck Pilot Program webpage .

https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing