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Articles 1 - 14 of 14
Full-Text Articles in Law
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 …
Federalization's Folly, Stephen F. Smith
Federalization's Folly, Stephen F. Smith
Journal Articles
Overcriminalization and overpunishment are the two key features of federal criminal law today, yet the constant drumbeat to “federalize” criminal law has accomplished precious little in terms of public safety. The failed drug war proves as much: federal prosecutors have filled the nation’s prisons with low-level drug dealers and drug users serving long sentences, but drugs remain widely available at greater purity and lower prices throughout the land — and drug overdoses are at record highs. Instead of focusing on areas of federal comparative advantage, such as terrorism, international drug trafficking, and organized crime, federal prosecutors waste scarce resources “playing …
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Journal Articles
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …
Memory And Punishment, O. Carter Snead
Memory And Punishment, O. Carter Snead
Journal Articles
This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, …
Private Regulation And Foreign Conduct, Adam I. Muchmore
Private Regulation And Foreign Conduct, Adam I. Muchmore
Journal Articles
Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …
Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Journal Articles
This Commentary is part of a colloquy on race-based genetics research.
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Journal Articles
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski
United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski
Journal Articles
This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.
Whose Team Am I On Anyway - Musings Of A Public Defender About Drug Treatment Court Practice, Mae C. Quinn
Whose Team Am I On Anyway - Musings Of A Public Defender About Drug Treatment Court Practice, Mae C. Quinn
Journal Articles
No abstract provided.
Terry, Race, And Judicial Integrity: The Court And Suppression During The War On Drugs, Jack B. Weinstein, Mae Quinn
Terry, Race, And Judicial Integrity: The Court And Suppression During The War On Drugs, Jack B. Weinstein, Mae Quinn
Journal Articles
No abstract provided.
The 1988 U.N. Convention Against Illicit Traffic In Narcotic Drugs And Psychotropic Substances - A Ten Year Perspective: Is International Cooperation Merely Illusory?, Jimmy Gurule
Journal Articles
On the ten-year anniversary of the adoption of the 1988 U.N. Drug Convention, this Article analyzes whether signatory- parties have complied with the duties and obligations imposed thereunder, and, in particular, whether the Convention has enhanced international cooperation in narcotics enforcement. Part I of this Article examines the legal obligations and duties imposed under the 1988 U.N. Drug Convention, with special emphasis on the provisions aimed at criminalizing money laundering and at forfeiture of illicit drug proceeds and instrumentalities of narcotics trafficking. Additionally, Part I examines the requirement that parties afford one another the "widest measure of mutual legal assistance …
What Will Become Of Prohibition, Clarence Emmett Manion
What Will Become Of Prohibition, Clarence Emmett Manion
Journal Articles
Because of the substantial minority support for Prohibition and the Eighteenth Amendment, this article suggests that it would difficult, if not impossible, to repeal the amendment despite the fact that 3 in 5 Americans would support its repeal. The article looks at potential options of lessening the impact of the Eighteenth Amendment, including removing penalties for it, repealing State enforcement acts, and forbidding nullification of search warrant requirements. Finally, it looks at the quality of liquor as a solution to an "unusually interesting" and "ultimately worthwhile" problem.
What Price Prohibition, Clarence Emmett Manion
What Price Prohibition, Clarence Emmett Manion
Journal Articles
Prohibition assumes that our plan of government has not worked out and that it ought to be destroyed; the average citizen who has loved that form of government and fought for it in and out of the ranks is not prepared to accept the Prohibition theory. Sooner or later he will realize that as long as Prohibition is in vogue the goddess of American liberty is in chains. Formally or informally, in justification of our history Prohibition with all of its contemptible un-American ramifications must go down; and it will go down.