Browsing HLS Student Papers by Title
Now showing items 233-252 of 498
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THE INADEQUATE RESPONSE OF THE FDA TO THE CRISIS OF AIDS IN THE BLOOD SUPPLY
(1995)The response of the blood industry and the Food and Drug Administration (FDA) to the problem of acquired immune deficiency syndrome (AIDS) in the nation's blood supply has been called "inadequate and abysmal," "unnecessarily ... -
Incrementalism in Pharmaceutical Research: Incentives and Policy Implications
(2006)The tremendous commercial success of drugs which scientific data suggest are of no benefit to most patients relative to pre-existing drugs is illustrative of a phenomenon in pharmaceutical markets whereby products can ... -
AN INDECIPHERABLE DEBATE? AN OVERVIEW OF OPPOSING PERSPECTIVES AND THE SEARCH FOR A COHERENT REGULATORY SCHEME FOR THE REPROCESSING AND REUSE OF SINGLE-USE MEDICAL DEVICES
(2000)Caught in the middle of this controversy, the FDA has struggled for only the past few years to devise a conclusive regulatory strategy for medical device reuse. Many critics claim, however, that this action by the FDA comes ... -
Infant formula: A comparison of legislation in the United States and Taiwan
(2014-03-18)This paper examines and contrasts the legal framework in the United States and comparable legislation in Taiwan. Prompted by the Syntex incident, the U.S. Congress passed the Infant Formula Act of 1980, and delegated the ... -
THE INFERTILITY INDUSTRY: INSPIRING TECHNOLOGY GIVES BIRTH TO COMPLEX MORAL UNCERTAINTIES
(2002)Assisted reproductive technologies (ART) are rapidly advancing, permitting more couples and individuals to overcome their infertility. These advances, taking place largely outside the reach or view of government regulation ... -
Informal Guidance and the FDA
(2011)This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of ... -
"Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform
(2001)To demonstrate the inadequacies of informed consent in the contemporary context and the need for better subject protection, this paper begins by scrutinizing the rise of modern informed consent doctrine in international ... -
Injury in Fact, Then and Now (and Never Again): Summers v. Earth Island Institute and the Need for Change in Environmental Standing Law
(2009-11-20)This article has 3 goals: to describe the origins and development of environmental standing law, to present theoretical objections to the requirement that environmental plaintiffs demonstrate an “injury in fact” as it is ... -
Inside Insite: How a Localized Social Movement Led the Way for North America’s First Legal Supervised Injection Site
(2015)This paper explores the connection between law and social change by looking at Insite, North America’s first legal supervised injection site, as a case study. The paper focuses on how the Canadian Supreme Court was primed ... -
Insufficient FDA Resources: Levelling the Playing Field and Reducing Fraud by Altering Incentives
(2001)This paper seeks to explore the problems illustrated by the Procter and Gamble orange juice example ; namely, the peculiar side effects of inadequate FDA funding upon competition and rule compliance. Part I of this paper ... -
INSURANCE COVERAGE OF PRESCRIPTION CONTRACEPTIVES
(2002)Since the FDA approved the first oral contraceptive in the 1960s, prescription contraceptives have become a major part of women’s health care. Yet even though contraceptives are central to womenâ ... -
Interlocking Directorates in the European Union: An Argument For Their Restriction
(2016)The EU Commission has recently undertaken a review of the EU Merger Regulation. In this process it has published a White Paper that proposes to extend the Regulation to cover situations in which firms acquire minority ... -
Internet Hoaxes: Public Regulation and Private Remedies
(2000)This paper begins with a brief overview of the psychology of rumor and a discussion of the impact of Internet technology on the dissemination of rumors. Part II examines the three consumer rumors presented above as case ... -
Internet Pharmacies: Regulatory Problems and Potential Solutions
(2002)This paper will analyze the growing problem “rogue†Internet pharmacies—Internet pharmacies that conduct illegal or unsafe prescribing and dispensing practices that endanger ... -
Intrinsa: An Inquiry into Female Sexual Dysfunction and Testosterone
(2006)In December 2004, the Food & Drug Administration rejected Intrinsa, a testosterone transdermal system for the treatment of hypoactive sexual desire disorder in surgically menopausal women. Intrinsa, as well as the FDA's ... -
Is Rulemaking Old Medicine at the FDA?
(1997)The first three parts of this paper describe the major burdens placed on agency rulemaking by each branch of the government over the past thirty years, with specific focus on the burdens that presently affect FDA rulemaking. ... -
"Is the Copy Better than the Original? The Regulation of Orphan Drugs: a US-EU Comparative Perspective"
(2004)The US Orphan Drug Act of 1983 pioneered the regulation of this type of medicines, and its success encouraged other countries to enact similar legislation. Among these new orphan drug laws is the one that was drafted in ... -
Is the FDA Sexist? Sex and the Drug Approval Process
(2003)This paper examines the role of sex in the drug approval process. Medical literature has explored in great depth the many ways in which men and women differ, sometimes dramatically, often in ways that are seemingly unrelated ... -
Jeremy Rifkin: An Examination of the Efforts of an Anti-Biotechnology Activist
(1999)This paper attempts retrospectively to examine the impact of the efforts of Jeremy Rifkin on the rules and regulation, and ultimately the mission, of the Food and Drug Administration (FDA) pertaining to biotechnology. ... -
THE JEWISH DIETARY LAWS AND THEIR FOUNDATION
(1994)While food and drug law has made its greatest contributions to the health and welfare of society over the past two centuries, it is indisputable that the history of this body of law is much older than two hundred years.1 ...