The Food and Drug Administration: Creation, Behavior, Regulatory Culture

Seeks to study the FDA on its own terms, from both inside and outside. Among many regulatory affairs specialists, the Food and Drug Administration represents an outside agent bent on slowing down the productive efforts to develop new drugs, medical devices, and biologics. In this view, the FDA is worthy of close examination only inasmuch as it impinges upon the development and marketing of particular products. Offers students an opportunity to understand the FDA as an organization beholden to its several stakeholder communities, including Congress, the executive branch, regulated industries, and patient advocacy groups. Appropriates theories and methods common to political science and sociology to explore the nature of regulatory cultures and limits of acceptable risks.

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