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352 - FDA Law: Doctrine, Policy, and Practice (2 hours)*

This course will introduce students to basic principles of food and drug law and examine how significant doctrines of constitutional, administrative, and criminal law have been elaborated and applied in the food and drug context. The United States Food and Drug Administration has a pervasive role in American society: the agency reports that it regulates products accounting for 20 cents of every dollar spent by consumers. Infused by the instructor's experience of nearly 30 years of legal practice in the field, in both government and industry, the course will also explore the complex interplay of legal, ethical, policy, scientific/medical, and political considerations that underlie FDA’s regulatory authority, its policy-making, and its enforcement activity. "Case studies" will predominate in the curriculum. They are intended to bring the material “to life” – to illustrate the practical experience of lawyers, and FDA's policy and enforcement choices, in the crucible of managing highly challenging regulatory issues.
* This course may be offered for 3 hours during some years.