EMA, US FDA Worry About AI’s Pitfalls And Promises

The “garbage in, garbage out” issue remains top of mind as AI models continue to be integrated into drug development. The FDA still has a lot of learning to do, Jacqueline Corrigan-Curay says.

AI and human hand
Could AI exacerbate clinical trial diversity concerns? • Source: Shutterstock

US and European officials have big plans for artificial intelligence, including use in application review and safety signal identification, but both regulators remain concerned about the software’s limitations.

AI could help sponsors identify potential new drug targets or analyze the increasing volume of drug safety reports received each...

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