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Full-Text Articles in Law
Introduction To The Bremer-Kovacs Collection: Historic Documents Related To The Administrative Procedure Act Of 1946 (Heinonline 2021), Emily S. Bremer, Kathryn E. Kovacs
Introduction To The Bremer-Kovacs Collection: Historic Documents Related To The Administrative Procedure Act Of 1946 (Heinonline 2021), Emily S. Bremer, Kathryn E. Kovacs
Journal Articles
Few statutes have a legislative history as rich, varied, and sprawling as the Administrative Procedure Act of 1946 (APA). In recent years, courts and scholars have shown increased interest in understanding this history. This is no mean feat. The APA’s history spans nearly two decades, and it includes numerous failed bills, a presidential veto, and a full panoply of congressional documents. In addition, much of the most crucial documentation underlying the APA was produced outside of Congress—by the executive branch—and even outside of government—by the American Bar Association. Identifying and locating all the relevant documents is difficult. Understanding each piece …
The Undemocratic Roots Of Agency Rulemaking, Emily S. Bremer
The Undemocratic Roots Of Agency Rulemaking, Emily S. Bremer
Journal Articles
Americans often credit—or blame—Congress for the laws and policies that govern their lives. But Congress enacts broad statutes that give federal administrative agencies the primary responsibility for making and enforcing the regulations that control American society. These administrative agencies lack the political accountability of those in public office. To address this democratic deficit, an agency seeking to adopt a new regulation must publish a notice of proposed rulemaking and provide an opportunity for the public to comment on the proposal. Heralded as “one of the greatest inventions of modern government,” the Administrative Procedure Act’s (APA) notice-and-comment rulemaking procedure is understood …
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 …