Pharmaceutical Executive May 16, 2024
In an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development.
PE: Today, you were featured in a keynote interview titled “The AI view from the FDA.” For our audience, can you briefly explain what the discussion entailed and any questions that stood out to you?
Fakhouri: One of the points that came up that I thought was interesting was FDA’s experience with submissions that include AI and machine learning components. What I described was that since 2016, we’ve received over 300 submissions with AI and machine learning components across different stages of drug development, with the vast majority being in...
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