The US Food and Drug Administration has selected seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to support development of new US pharmaceutical manufacturing facilities through earlier US Food and Drug Administration engagement.
The pilot program was launched by the US Food and Drug Administration (FDA) on February 1, 2026, following Executive Order 14293 and a public meeting on challenges and opportunities to facilitate domestic manufacturing. According to the agency, the program is intended to encourage earlier FDA engagement and provide a more predictable regulatory pathway for companies planning to manufacture drugs for the US market.
The FDA received more than 80 requests to participate between February 1 and March 1, 2026. Eligible companies proposed new US manufacturing facilities intended to produce drug products that address supply gaps or expand access to therapies for unmet medical needs. Companies also committed to submitting a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement that relies on the new manufacturing facility.
According to the FDA, agency experts reviewed submissions using standardized evaluation criteria that assessed the proposed products, facility development progress, expected timelines for US market entry, and manufacturing innovation.
The selected companies are Amneal Pharmaceuticals, Cellares Corp., Eli Lilly and Company, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, Inc., and Regeneron Pharmaceuticals, Inc. The proposed facilities will support production of sterile liquid drug products, active pharmaceutical ingredients, biotechnology drug substances, sterile injectables, cell-based gene therapies, adeno-associated virus-based gene therapies, commercial-scale cell culture biomanufacturing, and protein therapeutics.
Participants will engage with the FDA through a two-phase model. During Phase 1, Facility Readiness, participants receive early technical guidance before facilities become operational, including review of facility information submitted through a facility-specific Drug Master File. During Phase 2, Application Submission, participants have opportunities for facility-focused presubmission meetings that are intended to support expedited facility evaluation and earlier inspections during the review process.
According to the FDA, the PreCheck Pilot Program promotes earlier interactions between the agency and companies with the goal of reducing uncertainty related to manufacturing readiness. The agency stated that earlier engagement may help identify facility-related issues before they affect review of marketing applications. Additionally, the agency stated that it will continue to evaluate implementation of the pilot program and assess opportunities to inform future program development.
Source: US Food and Drug Administration
