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Full-Text Articles in Law

Decoding Nondelegation After Gundy: What The Experience In State Courts Tells Us About What To Expect When We're Expecting, Daniel Walters Jan 2022

Decoding Nondelegation After Gundy: What The Experience In State Courts Tells Us About What To Expect When We're Expecting, Daniel Walters

Journal Articles

The nondelegation doctrine theoretically limits Congress’s ability to delegate legislative powers to the executive agencies that make up the modern administrative state. Yet, in practice, the U.S. Supreme Court has, since the New Deal, shied away from enforcing any limits on congressional delegation. That may change in the near future. In Gundy v. United States, the Court narrowly upheld a delegation, and a dissent signaled deep doubts about the Court’s longstanding “intelligible principle” standard and offered a new framework to replace it. Subsequent events strongly suggest that the Court is poised to move in the direction contemplated by the …


Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore Jan 2022

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 …