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FDA Increases AI, ML, and NLP Tools for Surveillance
(Thursday, August 1, 2024) The FDA has an office dedicated to studying the safety of medications. In its annual report, the Office of Surveillance and Epidemiology (OSE) listed a summary of its activities last year. The most prominent information is the increased use of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) tools to help with the review of the enormous amounts of data collected by the FDA. FDA continues to explore the use of AI and associated tools for routine tasks that used to take significant manual labor. FDA now uses NLP for electronic medical chart reviews to generate and analyze safety data. OSE also uses an AI tool for advanced data visualization using a tool called Information Visualization Platform (InfoViP). Among other things, the information generated by OSE is used for the evaluation of packaging and labeling of new drugs, review of postmarketing requirements, and in a few cases, review of real world evidence. While this information may seem less relevant to developers of new products, it is worth noting that similar tools can be used by the industry to evaluate the potential medication uses and errors prior to submission, and for designing better labels and packaging. The OSE Annual Report provides insight into how the FDA evaluates the post-market safety and utility of newly marketed drugs, which will provide useful pointers to what to look for when designing new drug development programs. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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