The FDA will begin accepting applications Feb. 1 for its PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain.
The program aims to increase regulatory predictability and streamline facility assessments for new U.S.-based pharmaceutical manufacturing sites, according to a Jan. 21 news release from the agency. Facilities will be selected based on alignment with national priorities such as development timelines, innovation and intended products for the U.S. market.
The FDA will accept applications through March 1 and plans to select its initial cohort by June 30. The agency said it will use the program to accelerate construction and readiness of domestic manufacturing sites by engaging with facilities earlier in their development process.
PreCheck incorporates feedback from stakeholders following a 2025 public meeting on onshoring pharmaceutical manufacturing. The FDA said the effort is part of a broader strategy to reduce drug shortages and safeguard public health by improving supply chain resilience.
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