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Pink Sheet Podcast: US FDA Adcomm Reform, Clinical Trial Modeling Boost, AI For Drug Review

Executive Summary

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Eliza Slawther, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider why the US Food and Drug Administration what an upcoming listening session means for the pace of advisory committee reform (:32), the potential impact of the agency’s Model Master File idea on the pharmaceutical industry (16:22), and what the UK Medicines and Healthcare products Regulatory Agency (MHRA)’s use of artificial intelligence in drug review could mean for sponsors (21:05).

More On These Topics From The Pink Sheet

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