FDA Launches PreCheck and Animal Drug Pilots to Boost US Manufacturing

The U.S. Food and Drug Administration (FDA) has launched two pilot programs aimed at strengthening domestic manufacturing of pharmaceuticals and animal drugs. The PreCheck Pilot Program, launched February 1, 2026, selected seven companies to receive earlier FDA engagement for new U.S. manufacturing facilities, while the Center for Veterinary Medicine (CVM) announced a separate pilot on July 21, 2026, to incentivize domestic manufacturing of animal drug products and active ingredients.

Under the PreCheck program, the FDA selected Amneal Pharmaceutical, Cellares, Eli Lilly and Company, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron Pharmaceuticals. The FDA received more than 80 requests to participate between February 1 and March 1, 2026, and said the cohort was intentionally kept small to allow the agency to gather data and refine the program before expanding. The selected facilities span small molecules, biologics, sterile injectables, biotechnology drug substance, cell-based gene therapies, AAV-based gene therapies, and commercial-scale cell culture biomanufacturing. The facilities include Amneal’s Long Island, New York, site for small-molecule sterile liquid products; Cellares’s Bridgewater, New Jersey, facility for cell-based gene therapy products; Eli Lilly’s Lebanon, Indiana, facility for active pharmaceutical ingredient manufacturing; Fujifilm Biotechnologies’s Holly Springs, North Carolina, site for commercial-scale cell culture biomanufacturing; Kriya Therapeutics’s Durham, North Carolina, facility for AAV-based gene therapy products; Kyowa Kirin’s Sanford, North Carolina, facility for biotechnology drug substance; and Regeneron’s Saratoga Springs, New York, facility for biotechnology drug substance, sterile injectables, and novel protein therapeutics.

The pilot uses a two-phase model. Phase I, Facility Readiness, provides early technical guidance before a site becomes operational, including FDA review of facility information submitted through a facility-specific Drug Master File. Phase II, Application Submission, includes facility-focused pre-submission meetings intended to support earlier inspections and more efficient facility evaluation during review. According to an FDA spokesperson, “PreCheck differs from standard regulatory pathways by moving the FDA engagement earlier into facility design and construction rather than waiting until after a drug application is submitted.” The program does not guarantee expedited approvals or favorable inspection outcomes and is limited to new domestic facilities.

The PreCheck program was launched under an executive order signed in May 2025 and is part of the administration’s push to onshore domestic manufacturing amid prolonged drug shortages and rising prices. An FDA spokesperson said an estimated 88% of active pharmaceutical ingredients (APIs) used in U.S. drugs are produced overseas, and 40% of U.S. generic drugs have only a single FDA-approved manufacturer. The CEO of pharmaceutical ingredient manufacturer Antheia called the program “a promising step toward removing regulatory bottlenecks and getting domestic manufacturing facilities online faster,” but said it must be combined with investment in modern infrastructure. The US Pharmacopeia has said geographic isolation of facilities, regardless of whether in the US or offshore, is a significant risk factor for shortages, and that single suppliers put the US at risk. The FDA spokesperson said future cohort size and timing will depend on industry feedback and program funding.

On July 21, 2026, the FDA’s Center for Veterinary Medicine launched a pilot to encourage and strengthen domestic manufacturing of animal drug products and active ingredients. The veterinary pharmaceutical supply chain, like its human drug counterpart, relies significantly on active ingredients and finished products manufactured outside the United States. The new program is intended to reduce the risk of supply chain disruptions by prioritizing reviews of animal drug applications where both the finished drug product and active ingredients are manufactured in the U.S. The program offers two primary incentives: priority review consideration for complete Chemistry, Manufacturing and Controls (CMC) technical sections when both the finished drug product and active ingredients are manufactured in the U.S., and the option for eligible sponsors to include a second domestic active ingredient source in an original application or technical section submission if at least one source is domestically manufactured, eliminating the need to submit a post-approval supplemental application. The animal drug pilot is modeled on approaches implemented by the FDA’s Center for Drug Evaluation and Research, including its ANDA Prioritization Pilot. CVM said it intends to monitor the pilot’s effectiveness and may modify the program based on stakeholder experience and feedback.