RIS: Computerized Labeling Assessment Tool Services (CLAT) (IT)

CLAT is a computerized labeling assessment tool being developed by the Food and Drug Administration to automate the review of drug labeling materials, including container labels, carton labeling, prescribing information, and Instructions for Use. Leveraging computer programming, image processing, and artificial intelligence, the tool will compare labeling content against a comprehensive library of FDA regulations, guidance documents, standards, and best practices to detect deviations, prevent medication errors, and ensure consistency across drug products and therapeutic classes. It will also track changes between versions to identify unintended errors introduced during updates, thereby enhancing operational efficiency, reducing manual review burdens, and supporting standardization across the agency’s medical product portfolio. Funding for CLAT is supported through both PDUFA and GDUFA, ensuring coverage of all CDER-regulated products, though no funding was allocated in FY24. The current project period ends September 30, 2024, and the agency plans to issue a new contract opportunity in mid-October 2024, followed by a task order in early FY25 with a one-year performance period aimed at delivering a Minimal Viable Product and preserving prior investment. Failure to continue funding risks losing critical expertise, resulting in significant delays and increased costs to reconstitute the team and regain technical momentum if the project is restarted.