Browsing HLS Student Papers by Title
Now showing items 141-160 of 498
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FDA Drug Approval: A Black and White Issue?
(2006)The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, ... -
FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses
(2002)This paper explores the way in which enforcement actions by the Food and Drug Administration (FDA) interact with certain constitutional rights, and it queries whether the system does its most to protect those rights while ... -
FDA Oversight of the Tissue Bank Industry
(2002)Until recently, FDA oversight of the human tissue industry has been spotty, even nonexistent. However, industry explosion has forced the FDA to not only publish general industry standards in 1993 (finalized in 1997), but ... -
FDA Premarket Regulation of Tissue-Engineered Replacement Parts for Humans
(2003)This paper is a description of tissue-engineered products, their potential for replacing conventional approaches to missing or failing tissues and organs, and FDA’s ongoing efforts to develop a comprehensive ... -
FDA Regulation and Patient Assisted Suicides
(1995)There are an increasing number of Americans who believe that the marginal benefit of surviving a few extra months is not worth the cost of suffering the pain, physical and/or mental deterioration, or increased dependency ... -
FDA Regulation and the New Anti-aging Products
(1995)In the decades since the enactment of the Federal Food, Drug, and Cosmetic Act (the "Act")' in 1938, one of the more persistent challenges facing the Food and Drug Administration (the "FDA") has been to apply an old statute ... -
FDA Regulation of Condoms: Minimal Scientific Uncertainty Fuels the Moral Conservative Plea to Rip a Large Hole in the Public's Perception of Contraception
(2005)This paper surveys the history of condom use, the underlying science, the FDA regulation of condoms and the recent debate on condoms and their effectiveness in preventing disease. In articulating the debate, perspectives ... -
FDA Regulation of Food and Drug Biotechnology
(1995)In its broadest sense, referring to the application of a biological process to provide a good or service, biotechnology has been affecting the human food supply for centuries In products such as beer and cheese. Similarly, ... -
FDA Regulation of Food Labeling
(1999)As one strolls down a grocery aisle, shift through the maze of cosmetic counters, or sits in front of the television, one is transported into various fantasies, identities, and scenarios. The power of advertisements and ... -
FDA Regulation of Health and Fitness Equipment
(2000)As new "quasi-medical" devices continue to push the bounds of the FDCA definition of a medical device and with growing popular support for using the FDA to regulate previously off-limit products such as tobacco, the FDA ... -
FDA Regulation of Imported Foods in an Age of Globalization
(2002)This essay will explore the intersection between the FDA’s regulation of imported foods and the United States’ obligations under the General Agreement on Tariffs and Trade (GATT) the ... -
FDA Regulation of Imported Non-Compliant Chinese Herbal Remedies
(1997)I've seen the past and it works! So wrote James Reston, a New York Times reporter, after being treated with acupuncture on the occasion of the removal of his appendix in Beijing in the early trade. At that point, arguably, ... -
FDA Regulation of Quack Devices: It's a Miracle!...or Is It?
(1994)Medical devices that presented substantial deception or an unreasonable and substantial risk of illness or injury have existed since the inception of this country. Even our forefathers such as Ben Franklin were subjected ... -
FDA vs. Ephedra: Dietary Supplement Regulation Under DSHEA
(2002)The Dietary Supplement Health and Education Act of 1994 (DSHEA) dramatically changed the way dietary supplements are regulated in the United States. DSHEA created a new category of products defined as “dietary ... -
FDA's Role in the Silicone Breast Implant Story
(1997)This paper will present the history of FDA's policy regarding silicone breast implants, as well as an analysis of the strengths and weaknesses of these actions. Although FDA Commissioner David Kessler's essential judgment ... -
The FDA's Treatment of Structure/Function Claims under the Dietary Supplement Health and Education Act
(2001)Demand in the United States for dietary supplements and herbal products has exploded in past years. One report states that demand for dietary supplements has increased almost 50 percent since 1995.1 Congress, therefore, ... -
The FDA's Use of Adverse Publicity
(1998)Of all the regulatory tools available to the FDA in fulfilling its duties, one of the most contentious and problematic is its use of adverse publicity. Whether it is because of its quasi-statutory status, the questionable ... -
FDA's Use of Negative Publicity as an Enforcement Mechanism
(2003)This paper analyzes FDA’s use of negative publicity as an enforcement mechanism, both generally and in the specific instance of the agency’s regulation of phenylpropanolamine ... -
The FDA’s Role in the Development of Bioterrorist Countermeasures
(2004)As the agency that approves drug products used to treat bioterrorist diseases, the FDA plays a significant role in the domestic preparation against a bioterrorist attack. The changes that occurred at the agency in response ... -
Federal Enforcement of the Controlled Substances Act: Striking a Balance Between Enforcement and the Regulation of Medical Practice
(2009)In the Controlled Substances Act of 1970, Congress made the conscious decision to vest the regulation and control of drugs in two executive branch departments. The Attorney General, through the DEA, is responsible for law ...