Lexology May 16, 2023
Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products” (“Second Discussion Paper”).[1] The Second Discussion Paper was issued by the Center for Drug Evaluation and Research (“CDER”), Center for Biologics Evaluation and Research (“CBER”), and Center for Devices and Radiological Health (“CDRH”), and from a scope perspective, the Second Discussion Paper discusses the use of AI/ML in drug and biologic development, as well as devices...
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