FDA Launches Inaugural PreCheck Pilot Program to Accelerate Domestic Drug Manufacturing
The U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical and biotech companies for its newly launched PreCheck Pilot Program, an initiative designed to accelerate the establishment of domestic manufacturing facilities, strengthen the U.S. drug supply chain, and reduce reliance on foreign production. Announced on June 29, 2026, the program is a direct response to Executive Order 14293, signed in May 2025, which mandated regulatory relief to promote domestic production of critical medicines.
According to the FDA, the PreCheck program aims to mitigate manufacturing and facility risks early in the development cycle, potentially shaving up to 14 months off the standard regulatory review timeline for new facilities.1
Selected Participants and Facilities
From a pool of over 80 applicants, the FDA selected seven companies with domestic facilities currently under construction:
- Eli Lilly and Company: Facility in Lebanon, Indiana, which will manufacture active pharmaceutical ingredients (API) for existing and future therapies.
- Regeneron Pharmaceuticals, Inc.: Facility in Saratoga Springs, New York, to manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics.
- Amneal Pharmaceuticals: Facility in Long Island, New York, to manufacture small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases.
- Cellares Corp.: Facility in Bridgewater, New Jersey, to manufacture cell-based gene therapies for oncology and hematology.
- FUJIFILM Biotechnologies: Facility in Holly Springs, North Carolina, supporting commercial-scale cell culture biomanufacturing.
- Kriya Therapeutics, Inc.: Facility in Durham, North Carolina, to manufacture AAV-based gene therapy products for chronic diseases.
- Kyowa Kirin, Inc.: Facility in Sanford, North Carolina, to manufacture biotechnology drug substance for rare diseases.
The Two-Phase PreCheck Model
The program operates on a structured, two-phase engagement framework:
- Phase 1 (Facility Readiness): Participants receive early technical guidance from the FDA before the facility is operational. This includes proactive reviews of facility-specific Drug Master Files (DMFs) to resolve potential issues before formal drug or biologics applications are submitted.
- Phase 2 (Application Submission): Participants gain enhanced engagement through facility-focused pre-submission meetings, allowing for expedited facility evaluations and enabling regulatory inspections earlier in the application review cycle.
Leadership and Industry Perspectives
"President Trump is rebuilding America's pharmaceutical manufacturing base because our nation's health and security depend on it. The FDA's PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the United States, strengthen our drug supply chains2, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines." — HHS Secretary Robert F. Kennedy Jr.
"Manufacturing and facility risks are usually the ones no one sees until a pre-approval inspection or a complete response letter, long after a sponsor has filed. PreCheck moves that conversation up by several years, to a time before a facility is even in operation, which is taking it off the critical path." — Eric Fulmer, SVP of Global Quality at Cellares
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An instance of Geopolitical rivalry forces sovereign regulators to streamline and repatriate drug manufacturing. — The FDA is actively bypassing standard post-operational inspectorial delays to bring drug manufacturing back onto sovereign soil. ↩︎
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An instance of Federal manufacturing fast-tracks shield critical clinical supply chains from geopolitical reliance. — To safeguard drug supply lines from geopolitical dependency, the FDA launched pre-clearance pilots to accelerate domestic manufacturing facility validations. ↩︎