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The U.S. Food and Drug Administration has begun accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the US, and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.
The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the US market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the US market.
FDA PreCheck consists of two phases. In Phase 1, the Facility Readiness Phase, selected manufacturers will engage with the FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings and inspections to resolve issues and expedite assessments of manufacturing information in a drug application.
For more information, including eligibility and selection criteria, visit the FDA PreCheck web page.
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