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Pink Sheet Podcast: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming

Executive Summary

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Interim Editor in Chief Nielsen Hobbs take a deep dive into the US Food and Drug Administration’s new clinical trial diversity action plan draft guidance and consider what information stakeholders may still want (:35), as well as discuss the agency’s plan to issue guidance on artificial intelligence use in regulatory decision-making (27:30).

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This and other podcasts are available on the Pink Sheet podcast page, as well as the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

 

 

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