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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 …
The Law And Economics Of Behavioral Regulation, Avishalom Tor
The Law And Economics Of Behavioral Regulation, Avishalom Tor
Journal Articles
This article examines the law and economics of behavioral regulation (“nudging”), which governments and organizations increasingly use to substitute for and complement traditional instruments. To advance its welfare-based assessment, Section 1 examines alternative nudging definitions and Section 2 considers competing nudges taxonomies. Section 3 describes the benefits of nudges and their regulatory appeal, while Section 4 considers their myriad costs—most notably the private costs they generate for their targets and other market participants. Section 5 then illustrates the assessment of public and private welfare nudges using cost-benefit analysis, cost-effectiveness analysis, and rationality-effects analysis.