FDA Selects Seven Participants for PreCheck Pilot Program to Advance US Drug Manufacturing
The program is intended to accelerate US drug manufacturing scale-ups and address unmet patient needs. Two companies familiar to our regenerative readers, Cellares and Fujifilm Biotechnologies, made the list!
Key Points
- FDA has selected seven companies for its PreCheck Pilot Program to support new U.S. drug manufacturing facilities.
- The program is designed to give companies earlier FDA engagement and a more predictable path for facility readiness and application review.
- Selected projects include sterile liquids, APIs, biologics, cell-based gene therapies, AAV-based gene therapies, and protein therapeutics.
FDA has selected seven companies to participate in the PreCheck Pilot Program, a new initiative to strengthen domestic drug manufacturing and improve the resilience of our supply chain. The program launched on February 1, 2026, aiming to give companies a leg up through earlier FDA engagement and a more predictable regulatory pathway for companies to get to market.
Selected Companies
To qualify, companies had to propose a new facility capable of producing therapies that address a market supply need, or improve patient access for unmet needs, and commit to submitting an NDA, BLA, ANDA, or a supplement tied to the new facility.
Out of about 80 applicants, here are the seven selected; you’ll notice a couple of cell & gene companies, which is incredibly exciting:
- Amneal Pharmaceutical: Long Island, New York facility for small molecule sterile liquid products in pain management, respiratory, and ophthalmic diseases
- Cellares: Bridgewater, New Jersey facility for cell-based gene therapy products in oncology and hematology diseases
- Eli Lilly and Company: Lebanon, Indiana facility for drug substance, or active pharmaceutical ingredients, supporting existing and future medicines
- FUJIFILM Biotechnologies: Holly Springs, North Carolina facility for commercial-scale cell culture biomanufacturing
- Kriya Therapeutics, Inc.: Durham, North Carolina facility for AAV-based gene therapy products targeting chronic disease conditions
- Kyowa Kirin, Inc.: Sanford, North Carolina facility for biotechnology drug substance for rare diseases
- Regeneron Pharmaceuticals, Inc.: Saratoga Springs, New York facility for biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases
These participants will work with FDA under a two-phase model:
- Phase 1, Facility Readiness: companies receive early technical guidance before the facility becomes operational, including review of facility information submitted through a facility-specific Drug Master File
- Phase 2, Application Submission: companies receive enhanced engagement through facility-focused pre-submission meetings intended to support earlier facility evaluation and inspections during the review cycle
More information is available on the FDA PreCheck Pilot Program webpage.
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