• PLoS medicine · May 2018

    Editorial

    The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

    • Michael S Sinha and Aaron S Kesselheim.
    • Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
    • PLoS Med. 2018 May 1; 15 (5): e1002564.

    AbstractIn a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.

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