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PLoS Med. 2018 May 8;15(5):e1002564. doi: 10.1371/journal.pmed.1002564. eCollection 2018 May.

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

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1
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.

Abstract

In 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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