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Pink Sheet Podcast: New US FDA Developments In AI Regulation

 
• By Pink Sheet Team

Pink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development.

Pink Sheet podcast
How will the work of CDER's AI Council get to the FDA's rank-and-file review staff? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Interim Editor-in-Chief Nielsen Hobbs discuss the impact of some recent US Food and Drug Administration news on artificial intelligence regulation, including the creation of a new AI Council in the Center for Drug Evaluation and Research (:39). They also discuss industry questions about inspections of AI-related products and other lingering regulatory uncertainties (5:07).

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