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Drugs, Biologics, and Devices: FDA Regulation, Intellectual Property, and Medical Products in the American Healthcare System  

Lewis Grossman

Print publication date:
Jan 2017
Online publication date:
Jul 2015
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 ... More

Genomics and the Law  

Maxwell J. Mehlman

Print publication date:
Jan 2017
Online publication date:
Jul 2015
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 ... More

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