Browsing HLS Student Papers by Title
Now showing items 291-310 of 498
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N2 Universal: A Case Study of an NDA
(1994)Food and drug law, like all areas of administrative law, is rife with tension among countervailing principles. The Food and Drug Administration is charged with protecting the health and safety of the American public. This ... -
The National Childhood Vaccine Act
(1994)Prior to passage of the National Childhood Vaccine Act in November 1986, manufacturers could be held strictly liable in tort for vaccine-related injuries, a lamentable situation which allegedly caused increasing prices, ... -
The National Strategic Stockpile: Will It Really Protect the Nation against Bioterrorism?
(2006)This paper assesses one of the key components of the nation’s defense against bioterrorism—the National Strategic Stockpile. The Stockpile was created by the Bioterrorism Act of 2002 ... -
The National Vaccine Injury Compensation Program: A Program Evaluation [Redacted Version]
(2003)To address these concerns and simultaneously encourage parents to have their children vaccinated, Congress enacted the National Childhood Vaccine Injury Compensation Act (the Act). The Act consists of two parts: (1) the ... -
THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS
(2002)This article will discuss the main mechanisms by which the United States and other countries are attempting to standardize their pharmaceutical regulations. I first explore the need for standardization and the potential ... -
The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues
(2004)The regulation off-label drugs is a complicated and controversial area of the law. Regulators must protect patients’ safety without interfering with physicians’ practice of medicine ... -
The New American Debtors' Prisons
(2015-08-04)Debtors’ prisons are back, in the form of imprisonment for nonpayment of criminal fines, fees, and costs. While the new debtors’ prisons are not historically or doctrinally continuous with the old, recent developments in ... -
New Approaches to the Methamphetamine Epidemic
(2004)Methamphetamine abuse has become an epidemic in the United States. As methamphetamine becomes increasingly available, more and more people are trying – and becoming addicted to – this ... -
A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics
(2005)Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety ... -
The New International Trade Architecture and Food Regulation
(2000)In analyzing the likely impact of the global trade regime on food safety, this study proceeds in the following way. Part I examines the Codex Alimentarius Commission's newly elevated status as the WTO designated key reference ... -
New Urbanist Design and Economic Growth: Lessons from Formalizing Smart Development in Miami (2012).
(2012)This work suggests that the keystone in beginning to improve the greatest ailments facing America’s cities lies in the design of the very form of those cities. This paper argues that providing smarter, more flexible options ... -
The Next Big Thing: Radiofrequency Identification Technology in Industries Regulated by the Food and Drug Administration
(2005)Radio-frequency identification (RFID) is an emerging technology that could have the most significant transformative effect on the world of commerce since the Internet became available to the masses Currently, RFID has ... -
The Next Frontier in Food: FDA Regulation of Genetically Engineered Animals
(2011)Genetically engineered (GE) animals designed for human use, whether to be eaten as food, to produce drugs, or to be enjoyed as pets, carry the potential for enormous benefits and enormous harm. Currently, the Food and Drug ... -
No Cranberries for Thanksgiving: The Impact of FDA Adverse Publicity
(2005)As the primary federal agency responsible for regulating the safety of food, drugs, medical devices, and cosmetics, The Food and Drug Administration (“FDAâ€) has enormous responsibility. With ... -
No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule
(2004)This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible. It gives a summary ... -
The North Korean Famine and Food Shortage: The Problem, the Politics, and the Policy
(2006)MODERN THEORIES OF FAMINE LARGELY CONCUR THAT FAMINE IS NOT THE SIMPLE CONSEQUENCE OF A LACK OF FOOD. TODAY, STUDIES CONFIRM THAT GLOBAL FOOD SUPPLIES ARE ADEQUATE TO CURE HUNGER AND PRESUMABLY, TO PROVIDE SUFFICIENT RELIEF ... -
“Not in a Month Without an ‘R’ in its Name”: An Historical Overview of 20th Century Seafood Regulation With a Glimpse of the Challenges at the Beginning of the 21st
(2002)Part I of this article introduces the American seafood and shellfish industry and provides some background data on the composition of the market as well as consumption patterns in the United States. Consideration is given ... -
Not Its Crowning Glory: Obstacles for FDA in Regulating Ingested Dietary Supplements Purporting to Prevent Hair Loss
(2005)Preventing hair loss is big business in the United States, amounting to over one billion dollars per year. While the industry is dominated by FDA-approved medications, like Propecia and Rogaine and hair transplant surgeries, ... -
Novartis AG v. Union of India: “Evergreening,” TRIPS, and “Enhanced Efficacy” Under Section 3(d)
(2013)A decision in Novartis AG v. Union of India, an Indian Supreme Court case, was announced April 1, 2013. The much anticipated decision has rocked the landscape of the pharmaceutical industry and public health in India because ... -
The Obesity Epidemic: Why and How the Government Must Act
(2004)This paper calls for the United States government – including, but not limited to, the Food and Drug Administration, the Federal Trade Commission, and Health and Human Services – to ...