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Expert Analysis

Does Research Tool Safe Harbor Cover AI Drug Development?

By Wallace Wu and Michelle Ban ( July 16, 2025, 6:47 PM EDT) -- In February, the U.S. Food and Drug Administration updated its discussion paper on the current and potential use of AI in the drug development process.[1] This paper provides an eye-opening overview of the diverse and evolving use of AI in seemingly every aspect of the drug development process: from drug target identification and selection, to pharmacokinetics and pharmacodynamics modeling in preclinical research, and to data analysis in clinical research.[2]...

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