Browsing HLS Student Papers by Title
Now showing items 300-319 of 498
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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 ... -
The Off-Label Use of Acepromazine Maleate
(2006)In this paper, I offer an evaluation of the off-label use of Acepromazine Maleate by foxhunters. In Chapter One, I provide readers with an explanation of the most important elements of the topic, including what Acepromazine ... -
Off-Label Use of Prescription Drugs should be Regulated by the FDA
(2003)The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) ... -
OFF-LABEL USES OF APPROVED DRUGS A New Compromise is Needed
(1995)Washington, D.C. is teeming with speculation regarding the likely effects of a new political scenery and the Republican Contract With America. As the new Congress is taking form and adjusting to a new reality, one voice ... -
The Office of Combination Products: Its Roots, Its Creation, and Its Role
(2005)The Office of Combination Products (OCP), within the Food and Drug Administration (FDA), was created formally by statute in December, 2002. Upon its creation, the Office became broadly responsible for overseeing the ... -
Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament
(2003)In early 2003, two panels of the Federal Circuit clashed in a pair of cases (Warner-Lambert v. Apotex and Allergan v. Alcon) dealing with the question of whether an action for inducement of infringement could be leveled ... -
On The Right to Get High
(2002)This paper argues that the criminalization of drugs, via the criteria the FDA [Food and Drug Administration] uses to put drugs into different schedules, is illegitimate on scientific and philosophical grounds. The most ... -
One Hundred Years of Shellfish Regulation
(1998)Shellfish, as a food category. has a distinctive history of regulation. Unlike meat and poultry, shellfish has never been subject to 100% mandatory product inspection by the federal government. This absence of inspection ... -
One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application
(2002)The doctrine of equivalents as applied to chemical patents is compared to the FDA’s findings of bioequivalence in reviewing suitability petitions for filing Abbreviated New Drug Applications (ANDAs). The ... -
ORAL CONTRACEPTIVES AND THE LEARNED INTERMEDIARY DOCTRINE
(2002)Ordinarily prescription drug manufacturers aren’t required to give direct warnings to patients regarding the risks associated with their products. Instead, manufacturers need only inform the prescribing ...