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

CLAT will provide a tool for FDA Reviewers that uses computer programming, image processing, and AI technologies to replace the manual (hands on) review of drug labeling, including container labels, carton labeling, prescribing information, and Instructions for Use. CLAT will auto-review the drug labeling against a library of FDA regulations, guidance's, standards, and best practices to help mitigate medication errors, increase operational and cost efficiencies, and standardize labeling across therapeutic drug classes and product types. CLAT will identify deviations between version changes and ensure no unintended errors have been introduced