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Articles 1 - 6 of 6
Full-Text Articles in Food and Drug Law
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
Getting A Handle On Growler Laws, Adam Star
Getting A Handle On Growler Laws, Adam Star
Seattle University Law Review
This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions such …
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Indiana Law Journal
This Note investigates the origins of Inwood that led to the slim opinion with wide influence. It argues that the very vagueness for which scholars and practitioners have decried Inwood is the case's greatest virtue: Inwood provides a flexible standard that has allowed the common law to evolve and address new business models. Part I discusses the origins of contributory infringement in intellectual property. Part II investigates the Inwood case and the climate of trademark law at the time Inwood was litigated. It also dissects the majority opinion and Justice White's concurrance. Part III examines the Inwood standard's evolution at …
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
Publications
Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Scholarly Works
In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.
Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth
Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth
David A. Wirth