The FDA has selected seven companies to participate in its PreCheck Pilot Program, an initiative designed to support domestic pharmaceutical manufacturing through earlier regulatory engagement and a more predictable review process.
The FDA first unveiled the PreCheck concept in August 2025 following an executive order President Donald Trump signed May 5, 2025, directing the agency to cut duplicative requirements, streamline facility approval timelines and support manufacturers earlier in the development process.
The agency began accepting applications Feb. 1 and received more than 80 during the one-month window, according to a June 29 agency news release.
The selected companies and their focus areas are:
- Amneal Pharmaceuticals: The company’s Long Island, N.Y., facility will manufacture sterile liquid products for pain management, respiratory and ophthalmic diseases.
- Eli Lilly and Co.: The company’s Lebanon, Ind., facility will manufacture active pharmaceutical ingredients.
- Regeneron Pharmaceuticals: The company’s Saratoga Springs, N.Y., facility will produce biotechnology drug substance, sterile injectables and novel protein therapeutics.
- Cellares Corp.: The company’s Bridgewater, N.J., facility will manufacture cell-based gene therapies for oncology and hematology diseases.
- Kriya Therapeutics: The company’s Durham, N.C., facility will manufacture AAV-based gene therapies for chronic diseases.
- Kyowa Kirin: The company’s Sanford, N.C., facility will manufacture biotechnology drug substance for rare diseases.
- Fujifilm Biotechnologies: The company’s Holly Springs, N.C., facility will support commercial-scale cell culture biomanufacturing.
The program is structured in two phases. In the first, participants receive early technical guidance from the FDA before their facility becomes operational, including review of facility information submitted through a Drug Master File — allowing the agency to identify and address potential issues before a drug application is submitted. In the second phase, companies gain access to enhanced pre-submission meetings and earlier inspection opportunities tied to their drug or biologics application.
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