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

The contract involves the development and provision of the Computerized Labeling Assessment Tool (CLAT) for FDA Reviewers, which leverages computer programming, image processing, and AI technologies to automate the review of drug labeling. This includes container labels, carton labeling, prescribing information, and Instructions for Use. CLAT will compare drug labeling to a comprehensive library of FDA regulations, guidance, standards, and best practices to reduce medication errors, enhance operational efficiency, and standardize labeling across various therapeutic classes and product types. It also monitors version changes to detect any unintended deviations, ensuring accuracy and compliance. The funding for this initiative is split between the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA), supporting all medical products under the Center for Drug Evaluation and Research (CDER). The current performance period ends on September 30, 2024, with plans to issue a new contract extension in mid-October 2024 and to submit a follow-up task order early in fiscal year 2025 for another year of development. Failure to secure continued funding risks losing critical expertise, leading to increased costs and delays due to the need to restart the project and overcome a steep learning curve.