Regulation of Investigational New Drugs: "Giant Step for the Sick and Dying"?
Nelson, Richard J.
GEORGETOWN LAW JOURNAL 77(2): 463-488, December 1988
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Kessler, David A. (1989-02-02)Elements of the process by which the U.S. Food and Drug Administration (FDA) regulates new drugs are examined in a discussion of the Investigational New Drug application (IND), the role of institutional review boards, ...