INFORMS Open Forum

New Research Finds New Data-driven Approaches Would Improve How FDA Monitors Safety of Approved Existing Drugs

  • 1.  New Research Finds New Data-driven Approaches Would Improve How FDA Monitors Safety of Approved Existing Drugs

    Posted 10-14-2021 10:50

    CATONSVILLE, MD, October 14, 2021 – New research in the INFORMS journal Management Science finds that the U.S. Food and Drug Administration (FDA) could enhance public safety by employing new, robust data-driven approaches to identify adverse effects of drugs faster and more reliably, which would improve the regulatory decision-making and oversight processes. This approach would substantially contrast with the current FDA approaches for monitoring drug safety, which suffers major drawbacks, e.g., that they are based on voluntary reports that can result in inaccurate or untimely decisions. 

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    Ashley Smith
    Public Relations Specialist
    INFORMS
    Catonsville MD
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