Jason Conaty

Hogan Lovells

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Latest Posts › Machine Learning

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FDA launches “Elsa” AI tool to aid drug approvals

The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

6/13/2025 / Algorithms , Artificial Intelligence , Clinical Trials , Drug Approvals , Food and Drug Administration (FDA) , Machine Learning , Pharmaceutical Industry , Prescription Drugs , Regulatory Agencies , Regulatory Oversight

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

5/19/2025 / Algorithms , Artificial Intelligence , Data Privacy , Data Security , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements

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

5/7/2025 / Animal Testing , Artificial Intelligence , Biotechnology , Clinical Trials , Food and Drug Administration (FDA) , Machine Learning , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements

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