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Articles 31 - 32 of 32
Full-Text Articles in Food and Drug Law
The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh
The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh
Faculty Publications
This article addresses the question as to whether a federal court has the authority to compel a pharmaceutical company to disgorge profits obtained from an alleged violation of the FDCA, specifically the failure of a pharmaceutical company to comply with current good manufacturing practices (GMPs). Section II of this article summarizes the article to which we are responding. In all fairness, it did not purport to be a full-blown defense, and we expect the agency's comprehensive defense of disgorgement would be considerably more detailed. Section III turns to the Sixth Circuit case on which FDA rests its argument for disgorgement, …
Regulation Of Pharmaceutical Advertising, Anthony S. Zito Jr.
Regulation Of Pharmaceutical Advertising, Anthony S. Zito Jr.
Cleveland State Law Review
Federal trade commission regulation of pharmaceutical advertising is a subject of considerable current interest. The criteria for determining the acceptability of these advertisements are still evolving, and a definitive set of rules has not yet been fully articulated. Nevertheless certain trends are developing.' One of the major objectives of this paper is to predict the ultimate form of these rules.