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  • UMB Dataset

    Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling

    Authors
    Peter Doshi
    Bansri Desai
    Kyungwan Hong
    John H. Powers, III
    Description

    Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which...

    Subject
    Drug Labeling/standards
    Access Rights
    Unrestricted access