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Technology assessment and the Food and Drug AdministrationThe statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.
Document ID
Document Type
Kaplan, A. H. (Kleinfeld and Kaplan Law Offices Washington, DC, United States)
Becker, R. H. (Kleinfeld and Kaplan Law Offices Washington, DC, United States)
Date Acquired
August 6, 2013
Publication Date
January 1, 1972
Publication Information
Publication: George Washington Univ. Technol. Assessment: Understanding the Social Consequences of Technol. Appl.
Subject Category
Distribution Limits
Work of the US Gov. Public Use Permitted.