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Assessing Visions Of Democracy In Regulatory Policymaking, Shoba Sivaprasad Wadhia, Christopher J. Walker
Assessing Visions Of Democracy In Regulatory Policymaking, Shoba Sivaprasad Wadhia, Christopher J. Walker
Journal Articles
Motivated in part by Congress’s failure to legislate, presidents in recent years seem to have turned even more to the regulatory process to make major policy. It is perhaps no coincidence that the field of administrative law has similarly seen a resurgence of scholarship extolling the virtues of democratic accountability in the modern administrative state. Some scholars have even argued that bureaucracy is as much as if not more democratically legitimate than Congress, either in the aggregative or deliberative sense, or both.
In our contribution to this Ensuring Democratic Accountability in the Administrative State Symposium, we make a modest intervention …
Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore
Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore
Journal Articles
This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than
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 …