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A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers

William M. Janssen, Charleston School of Law

Abstract

In FDLI's principal work on off-label medicine, this Chapter summarizes the evolution of off-label practices (including use, prescription, and promotion), tracks the development of the law on these issues, and discusses the future legal challenges that still await a firm resolution.

Suggested Citation

William M. Janssen. "A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers" Off-Label Communications (1st ed). Ed. Mark C. Levy. Washington, D.C.: Food & Drug Law Institute, 2008. i-217.

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