Uncertainty remains for inspections and automation as industry navigates the use of artificial intelligence and machine learning in product development and awaits formal US Food and Drug Administration guidance.
At a recent FDA/Clinical Trials Transformation Initiative meeting on AI in drug and biological product development, panelists said that regulatory uncertainty as well as the biopharma industry’s longstanding aversion to risk
Key Takeaways
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Drug developers seek more clarity from the FDA about inspection expectations when AI elements are used in drug development.
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AI models may run without any human element in some limited contexts of use, FDA officials said
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