The U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical companies to participate in its new PreCheck Pilot Program, an initiative designed to accelerate the review of new domestic drug manufacturing facilities by engaging with companies earlier in the construction process. The program aims to strengthen the U.S. pharmaceutical supply chain, expand domestic manufacturing capacity, and reduce delays in bringing new medicines to market.
- The FDA has selected seven companies for its new PreCheck Pilot Program.
- Participants include Eli Lilly, Regeneron, Fujifilm Biotechnologies, Amneal, Cellares, Kriya Therapeutics, and Kyowa Kirin.
- The program allows the FDA to begin reviewing manufacturing facilities before construction is complete.
- Early regulatory engagement could shorten facility review timelines by up to 14 months.
- The initiative is intended to strengthen U.S. drug manufacturing and improve supply chain resilience.
The seven selected companies were chosen from more than 80 applicants that submitted proposals earlier this year. According to the FDA, applicants were evaluated using an objective scoring framework that considered the products to be manufactured, the maturity of facility development, projected timelines for commercial production, and innovation in manufacturing design and operations. Eligible facilities also had to support products addressing unmet medical needs or drug supply shortages and commit to submitting a New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), or a related supplement tied to the new manufacturing site.
The selected participants are:
- Eli Lilly – Lebanon, Indiana facility producing active pharmaceutical ingredients (APIs) for obesity and diabetes medicines.
- Regeneron Pharmaceuticals – Saratoga Springs, New York manufacturing facility.
- Fujifilm Biotechnologies – Commercial-scale cell culture biomanufacturing site in Holly Springs, North Carolina.
- Amneal Pharmaceuticals – Long Island, New York facility producing sterile liquid medicines.
- Cellares – Bridgewater, New Jersey cell therapy manufacturing facility.
- Kriya Therapeutics – Durham, North Carolina gene therapy manufacturing site.
- Kyowa Kirin – Sanford, North Carolina drug substance facility focused on therapies for rare diseases.
The FDA launched the PreCheck Pilot Program in February 2026 following a public consultation on domestic pharmaceutical manufacturing and in response to an executive order promoting U.S.-based drug production. Rather than waiting until a manufacturing facility is completed before beginning regulatory assessments, the program enables FDA experts to work alongside participating companies throughout the design and construction process. The agency believes this earlier engagement can identify potential compliance issues before they become major obstacles during product review.
The pilot follows a two-phase model. During the first phase, known as Facility Readiness, FDA specialists will review facility designs, construction plans, manufacturing systems, and quality controls while facilities are still being built. Companies will also be able to submit facility-specific Drug Master Files and receive technical feedback before operations begin. The second phase focuses on product application readiness, including facility-focused pre-submission meetings, early regulatory discussions, and feedback on chemistry, manufacturing, and controls (CMC) documentation before formal marketing applications are submitted.
According to the FDA, this approach could reduce regulatory review timelines by up to 14 months by addressing manufacturing deficiencies before pre-approval inspections take place. Traditionally, companies often discover facility-related issues only after submitting a marketing application, potentially resulting in complete response letters or delays that postpone commercial production.
“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,” said U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
Acting FDA Commissioner Kyle Diamantas said the initiative is intended to make regulatory expectations more transparent while encouraging investment in domestic pharmaceutical manufacturing. According to the agency, earlier collaboration should provide manufacturers with greater certainty during facility development while maintaining existing standards for product quality and patient safety.
Several of the selected facilities represent major investments in advanced pharmaceutical manufacturing. Lilly’s Indiana campus is expected to produce active pharmaceutical ingredients for its expanding portfolio of diabetes and obesity medicines, while Fujifilm’s North Carolina site will manufacture commercial-scale biologics. Cellares is developing automated manufacturing technology for cell therapies, and Kriya Therapeutics’ facility will support production of adeno-associated virus (AAV)-based gene therapies. Regeneron’s New York facility will manufacture biologic drug substances and sterile injectable medicines, while Kyowa Kirin’s site will support treatments for rare diseases.
Industry leaders welcomed the program as a way to reduce late-stage regulatory uncertainty. Eric Fulmer, Senior Vice President of Global Quality at Cellares, said manufacturing and facility risks are often not identified until pre-approval inspections or regulatory review, making earlier engagement particularly valuable. The company said moving those discussions earlier in the development process removes manufacturing readiness from the critical path toward commercialization.
The PreCheck initiative forms part of broader efforts to expand pharmaceutical manufacturing within the United States. In recent years, major drugmakers have announced tens of billions of dollars in investments to build new production facilities as governments seek to reduce reliance on overseas manufacturing for essential medicines and strengthen supply chain resilience following disruptions experienced during the COVID-19 pandemic.
For the FDA, the pilot will also serve as a test program to evaluate whether earlier regulatory engagement can improve efficiency without compromising safety or quality standards. Lessons learned from the initial cohort are expected to inform future expansion of the program if it proves successful. By integrating regulatory oversight earlier into facility development, the agency hopes to create a more predictable pathway for pharmaceutical manufacturers while supporting faster access to critical medicines produced in the United States.
The U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical manufacturers to participate in its PreCheck pilot program, a new initiative designed to streamline manufacturing reviews and strengthen domestic drug production. The PreCheck program is intended to improve regulatory efficiency by allowing the FDA to evaluate manufacturing readiness earlier in the review process, helping bring medicines to patients more quickly while maintaining rigorous quality standards.
The initiative reflects the agency’s broader efforts to modernize regulatory oversight and support a more resilient pharmaceutical manufacturing ecosystem in the United States.
What Is the PreCheck Pilot?
The PreCheck pilot enables participating drugmakers to work more closely with the FDA before formal inspections and application reviews. By reviewing manufacturing information earlier, the PreCheck process aims to identify and address potential issues before they delay product approvals.
Supporting U.S. Pharmaceutical Manufacturing
The PreCheck initiative also aligns with broader efforts to encourage domestic pharmaceutical manufacturing. By making regulatory reviews more efficient, the FDA hopes to strengthen U.S.-based production capacity, reduce dependence on overseas manufacturing, and improve the resilience of the nation’s medicine supply chain.
The pilot program may also provide valuable insights that shape future regulatory modernization initiatives across the pharmaceutical industry.
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