Browsing HLS Student Papers by Title
Now showing items 79-98 of 498
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Criminal Liability Under the Food, Drug, and Cosmetic Act
(1995)The criminal provisions of the Federal Food, Drug, and Cosmetic Act (FDCA)' and the judicial interpretation thereof afford the Food and Drug Administration (FDA) great discretion, in determining both when and against whom ... -
The Criminalization of Innovation: FDA Misdirection in the Najarian and Burzynski Cases
(1997)Najarian and Burzynski seem the perfect examples of the amazing potential of the American medical establishment. Their visionary work in their respective fields should be celebrated as monumental contributions to society. ... -
The Cure at a Crossroads: The Intersection of Ethics and Ambition in AIDS Research
(2003)This paper explores the structure of the major code of ethics regarding human experimentation, the Nuremberg Code. The paper begins with an explanation of the modern ethical standards and how they were established. Following ... -
"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act
(1995)The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, ... -
Data Analytics and the Fight against Housing Blight: A Guide for Local Leaders
(Berkman Klein Center for Internet & Society, 2017) -
Decoding the Market's Reaction to Settlement Announcements
(2015)This study examines defendant stock price returns on the day preceding, the day of, and the day following announcements of settlements in various types of litigation from 2009 through 2014. I hypothesized that defendant ... -
Deconstructing the Regulatory Facade: Why Confused Consumers Feed their Pets Ring Dings and Krispy Kremes
(2006)Americans own more than 130 million cats and dogs and spend over $12 billion per year on commercial pet foods. The commercial pet food industry faces minimal substantive regulation, despite navigating several layers of ... -
The Delicate Dance of Immersion and Insulation: The Politicization of the FDA Commissioner
(2003)The Food and Drug Administration never has been and never will be completely insulated from politics; it exists and operates as an integral part of the federal government in Washington, DC, not in a vacuum. Nevertheless, ... -
The Department of Agriculture's Regulation of Poultry Under the Poultry Products Inspection Act of 1957
(1997)The purpose of this paper is to investigate the reasons how conflicts between the USDA and FDA create obstacles to effective public health policy exist in the United States. I will begin my investigation by briefly outlining ... -
Derivatives Safe Harbors in Bankruptcy and Dodd-Frank: A Structural Analysis
(2013)The Bankruptcy Code exempts financial derivatives and repurchase agreements from key provisions, such as the automatic stay. The primary rationale for this special treatment has been the fear that the failure of an important ... -
Determining Optimal Default Savings Rates For 401(K) Plans
(2015)Automatic enrolment in 401(k) plans has succeeded in increasing employee participation rates, but the impact on overall savings rates has been less than might have been expected, as some participants who would have previously ... -
Dietary Supplements: A Historical Examination of its Regulation
(2002)The subject of this paper is the regulation of dietary supplements, with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) marked as a turning point. The paper examines the history of regulation ... -
Dietary Supplements: A Review of United States Regulation with Emphasis on the Dietary Supplement Health and Education Act of 1994 and Subsequent Activity
(2004)This paper undertakes a review of notable dietary supplement regulation in the United States. First, this paper discusses dietary supplements generally and their uses and economic characteristics. Second, this paper discusses ... -
A Difficult Proposition: Oral Contraceptives' Switch from Prescription to Over-the-counter Status
(1997)The choice between maintaining oral contraceptives at their current prescription drug status or switching the drugs to over-the-counter status, like so many other decisions in Food and Drug Law, has as much to do with ... -
Direct-to-Consumer Advertising of Alzheimer’s Disease Drugs
(2012)Use of direct-to-consumer (DTC) advertising by pharmaceutical manufacturers has skyrocketed in the past few decades as patients demand more information on drugs and the FDA has gotten more relaxed in its regulation of ... -
Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws
(2002)The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) approval process relating to new drugs and the treatment ... -
DISEASE-PREVENTION CLAIMS AND THE FIRST AMENDMENT: "WHO WILL PROTECT US FROM OUR PROTECTORS?"
(1994)The area of disease-prevention claims ("health claims") for food poses a broad spectrum of dilemmas that often arise in the food and drug law area and in other regulatory situations. These recurring questions include: How ... -
The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis
(1997)Over the years, the Food and Drug Administration ("FDA") has consistently asserted that it does not regulate the practice of medicine (the "Practice of Medicine Exception") . This prohibition has never been specifically ... -
DNA Sequences as Unpatentable Subject Matter
(2001)Man has played no part in creating DNA. It is nature which created and perfected DNA over thousands of years of evolution. What required man’s ingenuity was isolating, purifying, and sequencing the DNA. ...