FDA Selects Seven Companies for PreCheck Pilot Program to Boost Domestic Drug Manufacturing

The FDA has selected seven pharmaceutical and biotechnology companies to participate in its newly launched PreCheck Pilot Program, an initiative designed to strengthen domestic drug manufacturing by offering earlier regulatory engagement and a more predictable approval pathway for companies constructing new U.S.-based facilities. The program, which launched on February 1, 2026, was established in response to Executive Order 14293 signed by President Trump in May 2025, directing regulatory relief to promote domestic production of critical medicines.

The agency received more than 80 requests to participate during the application window, which ran from February 1 through March 1, 2026. FDA drug and biologic experts 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 the U.S. 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."

Selected Participants and Their Facilities

The seven companies chosen for the program represent a diverse cross-section of the pharmaceutical industry, spanning small molecules, biologics, cell-based gene therapies, and active pharmaceutical ingredient (API) manufacturing:

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

How the Two-Phase PreCheck Model Works

The pilot operates on a two-phase model designed to minimize uncertainty associated with manufacturing readiness. In Phase 1, focused on facility readiness, participants receive early technical guidance from the FDA before their facility becomes operational, including reviews of facility information submitted through a facility-specific Drug Master File. This allows the FDA to assess and help refine facility readiness before a drug or biologics application is submitted.

Phase 2 covers application submission, enabling participants to gain access to enhanced engagement through facility-focused pre-submission meetings. These meetings are intended to support expedited facility evaluation and enable inspections earlier in the review cycle. By facilitating earlier resolution of manufacturing issues, the program is intended to support the timely availability of critical drugs for Americans.

Eligibility and Strategic Rationale

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 a commitment to submit a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement relying on the new facility.

"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."

The FDA stated it will continue to evaluate the program's implementation and assess opportunities to inform future development of the PreCheck model. The PreCheck model enables FDA expertise and feedback to inform the acceleration of the facility development process from the outset, while allowing the agency to identify potential facility issues before they result in deficiencies that could delay or prevent application approval.