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Full-Text Articles in Law
Statutory Interpretation And Agency Disgorgement Power, Caprice L. Roberts
Statutory Interpretation And Agency Disgorgement Power, Caprice L. Roberts
Journal Articles
What happens when obstacles foreclose claims and threaten to leave parties without adequate relief? Or, when the cause of action escapes conventional classification? Or, when Supreme Court decisions frustrate private litigation causing pressure for public enforcement by agencies? Or, when individuals engage in novel forms of wrongdoing that the law may fail to reach? It becomes hard to resist the siren call of equity and its powerful remedies. This trend includes sweeping national injunctions, constructive trusts, and more. Disgorgement is also one such remedy, and its popularity is rising in terms of private and public applications and challenges. It is …
Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore
Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore
Journal Articles
In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.
The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …