Browsing HLS Student Papers by Keyword "regulation"
Now showing items 1-20 of 53
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ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK
(2002)The acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend ... -
The Anticompetitive Impact of Settlements in the Pharmaceutical Industry: The Need for Revisions to the Drug Price Competition and Patent Restoration Act of 1984
(2002)This paper will begin by briefly examining the theories behind antitrust law and intellectual property law. Then it will look at the provisions of the Hatch-Waxman Act and at how Congress tried to balance the incentives ... -
A Comprehensive Look at the Fair Packaging and Labeling Act of 1966 and the FDA Regulation of Deceptive Labeling and Packaging Practices: 1906 to Today
(2002)This paper discusses the regulation of packaging and labeling of foods throughout the 20th century, with a focus on the Fair Packaging and Labeling Act of 1966. The paper is divided into three sections: first, an overview ... -
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 ... -
Drug Reimportation: Prescription, Placebo, or Poison?
(2002)This paper examines drug reimportation as a means of reducing prescription drug prices paid by U.S. consumers. Specifically, this paper examines the provisions of the MEDS Act of 2000, which was passed by Congress right ... -
Ephedra and the FDA
(2001)The adverse events experienced after ingesting ephedra and other dietary supplements have demonstrated the need for FDA intervention. The FDA has an important role to play in safeguarding the health and safety of the ... -
FDA and the Challenge of Alternative Medicine: Realistic Assessments and Regulatory Flexibility
(1997)Alternative medicine has already established a role for itself in the health care of many Americans. FDA, however, has been slow to develop a meaningful and coherent regulatory response to this growing phenomenon. Reluctant ... -
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 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 ... -
A Felony To Drink Small Beer~ Reflections on Food and Drug Metaphors in Shakespeare
(1995)Some things don't change. Garlic and onions have always smelled less than perfumy on the breath--in Shakespeare's day and now. The images of food and drugs in Shakespeare are ubiquitous and reflect some of the same societal ... -
Folic Acid and the American Food Supply: A historical account of the FDA's creation of the current folic acid regulations
(2003)During the 1980s, scientific studies began to uncover a link between the B-vitamin folic acid and a reduction in the prevalence of neural tube defects, including spina bifida and anencephaly. When Congress passed the ... -
The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation
(2002)This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal ... -
THE FOOD AND DRUG ADMINISTRATION AND THE PROPOSED REGULATION OF CIGARETTES
(1995)Since the 1930s the Food and Drug Administration ("FDA") has taken broad Jurisdiction over eveiyday products in an attempt to ensure public health. Despite that mission, the FDA In particular and the Federal government In ... -
Food Labeling Regulation: A Historical and Comparative Survey
(2001)By tracing the history of food labeling laws, we can see that labeling regulation has come a long way from the branding of bread during the reign of King John in the thirteenth century. The food label has gone from a mere ... -
FOOD, DRUGS, AND THE ENVIRONMENT: HOW THE FOOD AND DRUG ADMINISTRATION HAS INTERACTED WITH THE NATIONAL ENVIRONMENTAL POLICY ACT OF 1969
(2000)The paper proceeds in three parts. Part II provides an overview of NEPA. The section examines the statutory text and foundational case law to understand how the statute operates and the obligations it imposes on agencies. ... -
From Creams to Lasers: Regulating the Beauty Industry in the New Millennium
(2002)The paper examines the development and use of lasers for cosmetic procedures. Given the lack of legal and regulatory literature in this important and growing area, the sole focus of this author in writing the paper is to ... -
From Regulation to Litigation: An Analysis of the Silicone Breast Implant Controversy
(2000)At the age of eighteen, Britney Spears has reached superstar status. She has sold millions of albums, and her music videos are among MTV's most popular. Teenage boys idolize her, and teenage girls strive to look like her. ... -
Gently Down the Stream: How Exploding Steamboat Boilers in the 19th Century Ignited Federal Public Welfare Regulation [REDACTED VERSION]
(2002)Boiler explosions plagued the steamboat industry during the early years of its existence (1816-1852), costing thousands of lives and prompting the federal government to enact private welfare regulation for the first time. ... -
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 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 ...