Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Administrative law (2)
- Biologic (2)
- Drug (2)
- FDA (2)
- Food (2)
-
- Regulation (2)
- Animal drug (1)
- Casebook (1)
- Color additive (1)
- Combination product (1)
- Cosmetic (1)
- Device (1)
- Dietary supplement (1)
- FDCA (1)
- FFDCA (1)
- Food additive (1)
- Food and drug (1)
- HCT/P (1)
- Health (1)
- Human tissue (1)
- Legislation (1)
- Medical device (1)
- Medical research (1)
- Pharmaceutical (1)
- Preemption (1)
- Regulatory (1)
- Statutory (1)
- Supplement (1)
- Tobacco product (1)
- Publication
- Publication Type
Articles 1 - 3 of 3
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
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
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 …
Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore
Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore
Books
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 comprehensive.