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FDA advances AI-powered review of medical product applications

If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

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