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Drugs, Biologics, and Devices

Lewis Grossman.

in The Oxford Handbook of U.S. Health Law

January 2017; p ublished online July 2015 .

Article. Subjects: Medical and Healthcare Law; Intellectual Property Law. 11152 words.

This article examines the basic framework of the U.S. Food and Drug Administration (FDA)’s approval process for drugs, biologics, and medical devices within the broader context of the...

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Genomics and the Law

Maxwell J. Mehlman.

in The Oxford Handbook of U.S. Health Law

January 2017; p ublished online July 2015 .

Article. Subjects: Medical and Healthcare Law; Intellectual Property Law. 10143 words.

This chapter explores the legal implications of the entire human genome, or “genomics.” It begins with an overview of scientific aspects of human genomics and a discussion of the history of...

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