SILVER SPRING, Md., June 29, 2026
The U.S. Food and Drug Administration (FDA) has announced the selection of seven pharmaceutical and biotechnology companies to participate in the FDA PreCheck Pilot Program, a new regulatory initiative designed to strengthen domestic pharmaceutical manufacturing, improve U.S. drug supply chain resilience, and accelerate patient access to critical medicines. The pilot program supports the development of new U.S.-based manufacturing facilities by encouraging early FDA engagement and creating a more predictable regulatory pathway for companies preparing to manufacture medicines for the American market. Launched on February 1, 2026, in response to Executive Order 14293, the initiative reflects a broader national effort to reduce dependence on foreign pharmaceutical production while expanding domestic manufacturing capacity for innovative medicines, biologics, gene therapies, and sterile injectable products. Following a competitive review process involving more than 80 applications, the FDA selected seven organizations whose proposed manufacturing facilities demonstrated strong potential to address market supply needs, improve patient access to therapies, and strengthen the nation’s pharmaceutical infrastructure.
Seven Companies Selected to Strengthen U.S. Drug Manufacturing
The FDA selected Amneal Pharmaceuticals, Cellares Corp., Eli Lilly and Company, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron Pharmaceuticals to participate in the inaugural PreCheck Pilot Program. The selected facilities span multiple states, including New York, New Jersey, Indiana, and North Carolina, and collectively represent a broad range of pharmaceutical manufacturing capabilities. Planned operations include the production of small-molecule sterile injectable medicines, active pharmaceutical ingredients (APIs), biotechnology drug substances, cell-based gene therapies, adeno-associated virus (AAV) gene therapies, sterile biologics, protein therapeutics, and commercial-scale cell culture manufacturing.
These facilities are expected to support treatments across numerous therapeutic areas, including oncology, hematology, respiratory diseases, ophthalmology, rare diseases, chronic illnesses, and advanced biologic therapies. The diversity of participating manufacturers highlights the FDA’s strategy to strengthen domestic production across both traditional pharmaceuticals and next-generation biologic medicines while improving long-term supply security for critical healthcare products.
Early Regulatory Engagement Designed to Accelerate Facility Readiness
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The FDA PreCheck Pilot Program introduces a two-phase regulatory framework intended to improve manufacturing readiness while reducing approval delays associated with new production facilities. During Phase 1, participating companies will receive early technical guidance from FDA experts, including facility evaluations supported through facility-specific Drug Master Files (DMFs) before manufacturing operations begin. This proactive engagement allows regulators to identify and resolve potential manufacturing issues before formal product applications are submitted. During Phase 2, companies will participate in facility-focused pre-submission meetings supporting earlier inspection planning and more efficient evaluation of future New Drug Applications (NDAs), Biologics License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and manufacturing supplements. By integrating FDA expertise throughout facility development, the agency aims to reduce regulatory uncertainty, improve manufacturing quality, and accelerate the availability of essential medicines.
The initiative also supports national efforts to enhance pharmaceutical self-sufficiency by encouraging advanced manufacturing technologies, increasing production capacity, and reducing reliance on overseas supply chains. The FDA stated that lessons learned from the pilot will help shape future regulatory modernization efforts while strengthening collaboration between regulators and industry. As global pharmaceutical supply chains continue to face increasing challenges, the FDA PreCheck Pilot Program represents an important step toward building a more resilient, innovative, and competitive U.S. pharmaceutical manufacturing ecosystem capable of ensuring reliable access to safe, effective, and high-quality medicines for patients nationwide.
Source: FDA press release
