FDA chose seven pharmaceutical and biotechnology companies to participate in its new PreCheck Pilot Program, an initiative designed to encourage domestic drug manufacturing by offering earlier regulatory engagement and a more predictable approval pathway for companies building new U.S.-based facilities.

Who Was Selected and What Will They Make?

FDA received more than 80 requests to participate during the application window, which ran from February 1 through March 1, 2026.¹ To be eligible, companies had to propose a new domestic manufacturing facility capable of addressing a market supply need or improving patient access for unmet medical needs, along with commitment to submit a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement relying on the new facility.²

FDA evaluated all requests using an objective framework and scoring rubric that considered the products to be manufactured, the stage of facility development, the anticipated timeline for bringing products to market, and innovation in facility development and manufacturing operations.

HHS Secretary Robert F. Kennedy Jr. framed the initiative in terms of national security and public health. "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," Kennedy said. "This is another important step toward making America healthier, stronger, and more self-reliant."

Companies who were accepted for the program include:

• Amneal Pharmaceutical: Long Island, New York facility will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases.
• Cellares Corp: Bridgewater, New Jersey site will produce cell-based gene therapy products for oncology and hematology.
  Eli Lilly & Company: Lebanon, Indiana facility will manufacture active pharmaceutical ingredients in support of the company's existing and future medicines.
• FUJIFILM Biotechnologies: Holly Springs, North Carolina plant will support commercial-scale cell culture biomanufacturing.
• Kriya Therapeutics: Durham, North Carolina facility will produce AAV-based gene therapy products targeting chronic disease conditions.
• Kyowa Kirin: Sanford, North Carolina site will manufacture biotechnology drug substance for rare diseases.
• Regeneron: Saratoga Springs, New York facility will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.

What is the PreCheck Pilot Program?

FDA launched the PreCheck Pilot Program on February 1, 2026, in response to an executive order signed by President Trump in May 2025 directing regulatory relief to promote domestic production of critical medicines.¹

The pilot operates on a two-phase model. Phase I focuses on facility readiness where participants receive early technical guidance from FDA before their facility becomes operational, including reviews of facility information submitted through a facility-specific Drug Master File.¹ This allows FDA to assess and help refine facility readiness before a drug or biologics application is submitted. The second phase covers application submission, enabling participants to gain access to enhanced engagement through facility-focused pre-submission meetings intended to support expedited facility evaluation and enable inspections earlier in the review cycle.¹

Why Does This Matter?

"This milestone reflects the Trump administration's commitment to strengthening domestic pharmaceutical manufacturing capacity, creating American jobs, and driving down drug costs for families," 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."

FDA said it will continue to evaluate the program's implementation and assess opportunities to inform future development of the PreCheck model.

Sources

1. FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing U.S. Food and Drug Association June 29, 2026 https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing
2. FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing U.S. Food and Drug Association February 1, 2026 https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing