Browsing HLS Student Papers by Title
Now showing items 199-218 of 498
-
The H2 Blockers' Rx-to OTC Switch: For Whom Will It Spell Relief?
(1995)Tylenol. Advil. Monistat 7. Imodium AD. These are some of the most commonly used, widely available, and successful drugs in the United States. All of them began as drugs only available by a prescription. All of them made ... -
Happy Inconsistency: Health Claims Standards at the FTC and FDA
(1997)We live in a society increasingly preoccupied with healthy food. Restaurant menus now include "heart smart" options, network news programs run segments on teenage vegetarians, consumer groups denounce our beloved movie ... -
Harmonizing Pharmaceutical Regulation Among the United States, the European Union, and Japan: The ICH Initiative
(2003)The United States, the European Union and Japan comprise 75% of the world's pharmaceutical market and generate 90% of all pharmaceutical research. Recognizing the need for and benefits of harmonized testing standards the ... -
Harvey Wiley, Theodore Roosevelt, and the Federal Regulation of Food and Drugs
(2004)The Roosevelt and Wiley story is important because it shows the role individuals can have on the course of history. Congressional passage of the Food and Drug Act, as well as the Meat Inspection Act, reflected sweeping ... -
The Hatch-Waxman (Im)Balancing Act
(2003)The Hatch-Waxman Act was intended to establish a balance between the competing interests of brand name and generic drug companies, fostering innovation while giving the public access to a wider selection of affordable ... -
Health Care Fraud Liability for Pharmaceutical Manufacturers
(2011)Fraud is an increasingly expensive cost to the health care industry, and the regulatory and prosecutorial focus during the fast few decades have focused on health care fraud by pharmaceutical manufacturers. This paper ... -
Health Effects & Wine: The FDA Should Regulate the Health Effects on Wine Labels
(2002)In 1976, the District Court of the Western District of Kentucky, in Brown-Forman Distillers Corp. v. Matthews, found that alcoholic beverages were exempt from the Food & Drug Administration labeling requirements. Since ... -
A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications
(2011)The Food and Drug Administration has recently rejected three drugs for the treatment of obesity based on safety concerns, engendering debate about the standards the Agency should use in evaluating weight loss medications. ... -
Herbs and the FDA: Current Regulation, Problems and Suggestions for Change
(2002)In this paper, I will discuss the current treatment of herbal products under DSHEA and describe some of the risks of herbal products. I will also talk about current FDA responses to these risks and provide some suggestions ... -
Herein of Scandal and Advancement: A Chronicle of Human Experimentation in the United States
(2011)An account of the history of human experimentation in the United States necessarily involves a recounting of scandals and the research policies that developed in response. This paper aims to provide a review of this ... -
The Hidden Costs of Sexier Lipstick: Animal Testing in the Cosmetic Industry
(1999)This paper does not argue, as the opening paragraphs of this section may seem to suggest, that animals should be seen as devoid of rights. On the contrary, it is filled with strong arguments pointing the other way. Its ... -
The Historical Development of Animal Toxicity Testing
(1997)This paper traces the historical development of animal toxicity testing, from its ancient origins through the period of standardization following World War II. It explores the roots of toxicity testing in physiology and ... -
The Historical Development of Cloning Technology and the Role of Regulation in Ensuring Responsible Applications
(2003)Recent developments in biotechnology have led to significant advances in the ability to clone mammals. Although the state of scientific understanding has not reached the point where the cloning of a human being from a fully ... -
The History and Future of Geographical Indications in Europe and the United States
(2005)Geographical indication is one of the most interesting problems in international trade law – how can we keep imitators from competing unfairly against distinctive local products? This paper traces the ... -
History and the Boundaries of Legality: Historical Evidence at the ECCC
(2013)The Extraordinary Chambers in the Courts of Cambodia (ECCC) are marked by the amount of time that has elapsed between the fall of Democratic Kampuchea in 1979 and the creation of the tribunal. Does this passage of time ... -
A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients
(2005)After the passage in 1962 of the Kefauver-Harris Drug Amendments that mandated that the FDA grant premarket approval for all drugs and added a requirement that drug manufacturers demonstrate the efficacy of their products, ... -
THE HISTORY OF ALCOHOLIC BEVERAGE LABELING REGULATION AND ITS IMPLICATIONS FOR A HEALTH CLAIM ON WINE LABELS
(1998)This paper has two main goals. First, it will provide a history of the FDA-ATF relationship with regard to jurisdiction over alcoholic beverage labeling regulation. This part of the paper will be largely descriptive in ... -
The History of Aspartame
(2000)These two opposing tensions, the market desire for low-calorie foods including sugar substitutes, and the fear of consumer manipulation by a burgeoning industry and a collusive FDA, drive the fascinating history of aspartame. ... -
THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY
(1999)This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the ... -
A History of Federal Control of Communicable Diseases: Section 361 of the Public Health Service Act
(2002)The federal government possesses broad powers under Section 361 of the Public Health Service Act to regulate the entry and spread of communicable diseases into and among the United States. Though this power has played a ...