Browsing HLS Student Papers by Title
Now showing items 314-333 of 498
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The Office of Combination Products: Its Roots, Its Creation, and Its Role
(2005)The Office of Combination Products (OCP), within the Food and Drug Administration (FDA), was created formally by statute in December, 2002. Upon its creation, the Office became broadly responsible for overseeing the ... -
Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament
(2003)In early 2003, two panels of the Federal Circuit clashed in a pair of cases (Warner-Lambert v. Apotex and Allergan v. Alcon) dealing with the question of whether an action for inducement of infringement could be leveled ... -
On The Right to Get High
(2002)This paper argues that the criminalization of drugs, via the criteria the FDA [Food and Drug Administration] uses to put drugs into different schedules, is illegitimate on scientific and philosophical grounds. The most ... -
One Hundred Years of Shellfish Regulation
(1998)Shellfish, as a food category. has a distinctive history of regulation. Unlike meat and poultry, shellfish has never been subject to 100% mandatory product inspection by the federal government. This absence of inspection ... -
One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application
(2002)The doctrine of equivalents as applied to chemical patents is compared to the FDA’s findings of bioequivalence in reviewing suitability petitions for filing Abbreviated New Drug Applications (ANDAs). The ... -
ORAL CONTRACEPTIVES AND THE LEARNED INTERMEDIARY DOCTRINE
(2002)Ordinarily prescription drug manufacturers aren’t required to give direct warnings to patients regarding the risks associated with their products. Instead, manufacturers need only inform the prescribing ... -
Origins of the Regulation of Raw Milk Cheeses In the United States
(2005)Artisanal cheese constitutes a subcategory of specialty cheese whose manufacture is characterized by its small scale, limited volume production, and individualistic producers. In recent years, artisanal cheese has been the ... -
OTC Sunscreen Drug Products: Towards Greater Protection
(1997)It is important for the public to know that sunscreens are not a panacea for the adverse effects of solar radiation and that they are not a substitute for avoidance of the sun. Along with the many benefits attributed to ... -
Out of Control: The Flawed Regulation of Schedule II Drugs and Its Impact on Pain and Addiction
(2004)This paper explores the current state of regulation of controlled substances at the federal and state level and analyzes how such regulations impact the undertreatment of pain and prescription drug abuse. Taking a historical ... -
Over 187 Billion Served: Food Safety in the National School Lunch Program
(2005)This paper explores the problem of food safety in the National School Lunch Program. After a brief history of the program and an account of its current operations and structure, particularly its mechanisms for ensuring ... -
Overload: Regulating the Sources of Information about Attention-Deficit/Hyperactivity Disorder
(2005)Information relating to attention-deficit/hyperactivity disorder (AD/HD) has flooded the consumer and medical markets in recent years. Information “overload†is often problematic, but it is ... -
Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action
(2012)On December 7, 2011, newspaper headlines from coast to coast announced that Plan B One-Step, a form of emergency contraception, would not be made available to females under seventeen without a prescription. The denial of ... -
Overview of Federal Regulation of Dietary Supplements: Past, Present, and Future Trends
(2000)This paper seeks to provide the researcher with a general overview of the past, present, and future of the federal regulation of dietary supplements. Part I of the paper briefly describes the regulation of dietary supplements ... -
Past, Present and Future in the Search for the Perfect Anti-epileptic Drug
(2002)This paper explores the development of anti-epileptic drugs, starting with the earliest forms of treatment, moving to the drugs currently in use and those recently approved by the FDA, and ending with the drugs (and devices!) ... -
The Past, Present, and Future of Direct-to-Consumer Genetic Testing: What we have Learned and Why Increased Regulation is Warranted
(2011)Almost a decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized ... -
Patent Law, Antitrust Enforcement, and Public Access to Pharmaceuticals and Medical Technologies
(2003)Patent and antitrust laws impact public access to pharmaceuticals and medical technologies. Two instances—one involving Roche’s new class of HIV/AIDS drugs, the other an antitrust ... -
Patents – the Starting Gun in the Race for the Human Genome
(2005)The race to sequence the human genome between the federal government’s Human Genome Project and the private firm Celera Genomics is one of the most fascinating tales in the history of science. This paper explores the role ... -
Paternalism, Hostility, and Concern for the Slippery Slope: Factors in Judicial Decision-Making When Religion and Regulation Collide
(1997)This paper will examine religious claims as they pertain to food and drug law issues, as exemplified by litigation surrounding 1) the Church of Scientology's use of an instrument known as the Hubbard Electrometer, and 2) ... -
PBM and Pharmaceutical Company Mergers: Policy and Regulatory Implications
(1994)A recent trend in the pharmaceutical industry has been for large pharmaceutical companies to acquire or merge with PBMs (prescriptionlpharmacy-benefits-management companies). Merck started this trend in November 1993 by ... -
Pelman v. McDonald's: An In-depth Case Study of a Fast Food & Obesity Lawsuit.
(2005)This paper analyzes a lawsuit filed against McDonald's by plaintiffs alleging that the restaurant chain bore liability for their obesity and health problems. The paper analyzes the plaintiffs' novel tort and statutory ...