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Food and Drug Law

2012

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Articles 31 - 60 of 75

Full-Text Articles in Law

Caremark's Irrelevance, Mercer E. Bullard Aug 2012

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …


Prosecutorial Discretion Revisited, Siyuan Chen Jul 2012

Prosecutorial Discretion Revisited, Siyuan Chen

Siyuan CHEN

Quek Hock Lye is the latest of three very recent Court of Appeal decisions that addresses the constitutional challenge against the exercise of prosecutorial discretion in the context of the Misuse of Drugs Act (the other two decisions being Ramalingam Ravinthran v Attorney General and Yong Vui Kong v Public Prosecutor). In Quek Hock Lye, the appellant Q was convicted of participating in a criminal conspiracy with W and S to traffic in not less than 62.14 grams of diamorphine (thus attracting the mandatory death penalty). Before Q’s trial began, W had pleaded guilty to a separate charge of possession …


Summer 2012 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law Jul 2012

Summer 2012 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.


Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon Jul 2012

Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon

Capstone Collection

The farm bill is an all-encompassing piece of legislation that is reauthorized approximately every five years and establishes federal policy for everything from farm subsidies and crop insurance to energy, conservation, food stamps and school lunches. The current law expires at the end of September 2012. Reauthorization of the farm bill represents the single largest opportunity to reform the policies that shape food systems in the United States. The Community Food Security Coalition (CFSC) is campaigning to improve access to healthy food by increasing links with family farmers and to strengthen local and regional food systems. This case study traces …


Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel Jun 2012

Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel

Georgia Journal of Public Policy

Discussions about public policy relating to alcohol cause a polarizing reaction to many people in this country, particularly in the South. The state of Georgia, for example, has a long history of policies regulating alcohol which reflects its membership as part of the “Bible Belt” where Sunday is regarded as a holy day and therefore alcohol cannot and should not be purchased on this day. Given that the impetus of alcohol control policy has generally widened the availability of alcohol since the Prohibition, the moral concerns of voters regarding alcohol regulation have been superseded in the public debate with safety …


American Indian Water Right Settlements, Darcy Bushnell Jun 2012

American Indian Water Right Settlements, Darcy Bushnell

Publications

No abstract provided.


Dynamics Of Land Use/Land Cover Changes And Its Implication On Food Security In Anyigba, North Central, Nigeria, Tokula E. Arome, Sunday P. Ejaro (Phd) May 2012

Dynamics Of Land Use/Land Cover Changes And Its Implication On Food Security In Anyigba, North Central, Nigeria, Tokula E. Arome, Sunday P. Ejaro (Phd)

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

This study assessed land use/land cover changes and its effect on Agricultural land in Anyigba. The objectives were to identify and delineate different land use / land cover categories, assess the rate of change that occurred and examine the impact of land use/land cover change on food security using satellite remote sensing data collected at three different years (1987 Land sat TM, 2001 Land Sat TM and 2011 Land Sat ETM). The study utilized GIS software such as Idrisi Andes academic and ArcGIS 9.3. The study area covers approximately 31.8km2, and four major land use/cover classes were utilized (built up, …


Intellectual Property, Traditional Knowledge, And Biodiversity In The Global Economy: The Potential Of Geographical Indications For Protecting Traditional Knowledge-Based Agricultural Products, Teshager W. Dagne May 2012

Intellectual Property, Traditional Knowledge, And Biodiversity In The Global Economy: The Potential Of Geographical Indications For Protecting Traditional Knowledge-Based Agricultural Products, Teshager W. Dagne

PhD Dissertations

The relationship between international regimes regulating intellectual property, traditional knowledge and biodiversity has received much attention in recent times. Of the many complex and controversial issues in contemporary international legal discourse on this matter, the protection of traditional knowledge (TK) stands out as a significant challenge. Choices abound in the search for modalities to regulate rights to use and control TK systems and their underlying biodiversity. In recent times, the protection of geographical indications (GIs) has emerged as an option for protecting TK. Despite the considerable enthusiasm over it, there is appreciable research dearth on how far and in what …


New Mexico Ex Rel. State Engineer V. Aamodt, No. 66cv6639 (D.N.M.), New Mexico State Engineer Apr 2012

New Mexico Ex Rel. State Engineer V. Aamodt, No. 66cv6639 (D.N.M.), New Mexico State Engineer

Publications

No abstract provided.


An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans Apr 2012

An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans

Mary Ann Chirba

Trying to buy a mercury thermometer at the local pharmacy these days will result in a deluge of information regarding the risks of mercury and the proper disposal protocol for mercury thermometers as hazardous waste. Yet, inquiring about the risks of placing mercury in one’s mouth, in the form of a dental filling, is likely to meet with resounding assurances of safety from the dental profession. While such comforting disclaimers are meant to ease patient concerns, many continue to worry about the safety of dental mercury. This article will begin by describing the many safety concerns that surround the use …


Regulating By Repute, David Zaring Apr 2012

Regulating By Repute, David Zaring

Michigan Law Review

Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …


Medicines That Kill, Lina Ahmed Abushouk Mar 2012

Medicines That Kill, Lina Ahmed Abushouk

Annual Undergraduate Conference on Health and Society

The prevalence of counterfeit drugs on the African continent has been increasing at an alarming rate. “Medicines that Kill” is a research paper that attempts to analyze the factors that make African countries particularly susceptible to this global threat. Nigeria, a country that has had some of the highest rates of counterfeit drugs in the world, is the main case study for this paper. Its efforts to combat the issue are compared and contrasted with those of Tanzania and Kenya in an attempt to understand what aspects of the issue are unique to Africa and the methods that have been …


Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy Mar 2012

Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy

Michigan Law Review

In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …


Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla Mcculley Feb 2012

Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla Mcculley

Claremont-UC Undergraduate Research Conference on the European Union

No abstract provided.


Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria, Ishaku Iy Mallo Phd, Victor G. Obasanya Jan 2012

Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria, Ishaku Iy Mallo Phd, Victor G. Obasanya

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

Abuja the Federal Capital Territory and study area is located between latitudes 8o25’ and 9o25’ North of the Equator and longitudes 6o45’ and 7o45’ East of the Greenwich Meridian. The study was carried out in Abuja Phase 1, and it is aimed at highlighting various socioeconomic effects of demolition of illegal structures and informal or squatter settlements on the people within the study area. Data was collected through reconnaissance survey, personal interviews with respondents, and a well laid out questionnaire. The results indicate that the demolition exercise embarked upon by the authorities in the Federal Capital Territory was a response …


Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria, Shaibu M. Hassan Phd Jan 2012

Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria, Shaibu M. Hassan Phd

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

This study aims at analyzing agro-climatological parameters and establishing a link between some selected agro-climatological indices and sustainability of agricultural production in the Federal Capital Territory (FCT). Two sets of data, climatic and crop yield data were collected and subjected to various agro-climatological analyses. Agro-climatological analyses include the derivation of Onset, Cessation and Length of Rainy Season (LRS), Seasonality Index, Drought Index and Precipitation Periodicity Index. The statistical analyses include monthly and annual means, deviation from the mean, trend line. The result of moisture index in line with crops optimum moisture requirement was used to classify the Territory into agro-climatic …


Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan Jan 2012

Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan

University of Michigan Journal of Law Reform Caveat

One of the lasting vestiges of Richard Nixon’s presidency is the infamous “War on Drugs,” a forty-year-old effort aimed at curtailing “illicit drug consumption and transactions in America.” Although the goal behind the policy—a reduction in the rate of substance abuse—may be altruistic, the War on Drugs has dismally failed to achieve its goals and has exacerbated existing problems. Specifically, laws dealing with crack cocaine result in a “heavily disproportionate impact on black defendants;” in 2008 “blacks comprised 79.8 percent of those convicted for crack cocaine-related offenses,” whereas “whites comprised only 10.4 percent.” More generally, these laws illustrate a fundamental …


Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson Jan 2012

Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson

University of Michigan Journal of Law Reform Caveat

Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …


Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled Jan 2012

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …


Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns Jan 2012

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Brooke Burns

This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.


Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin Jan 2012

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …


Polar Law And Good Governance, Prof. Elizabeth Burleson Jan 2012

Polar Law And Good Governance, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This chapter will assess the Antarctic Treaty System, ask what polar lessons can be learned regarding common pool resources, and analyze law of the sea and related measures. It will consider such substantive areas as Arctic and Antarctic natural resource management and procedural opportunities as inclusive governance structures. Enhancing good governance can occur through trust building forums that bring together stakeholders, share information, and make environmentally sound decisions regarding sustainable development.


The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven Jan 2012

The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven

Journal of Health Care Law and Policy

No abstract provided.


Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen Jan 2012

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …


One Size Does Not Fit All, David Spratt Jan 2012

One Size Does Not Fit All, David Spratt

Articles in Law Reviews & Other Academic Journals

No abstract provided.


A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud Jan 2012

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.


The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou Jan 2012

The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou

UIC Law Review

No abstract provided.


Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer Jan 2012

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.


Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness Jan 2012

Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness

Journal of Law and Health

This Article examines—and ultimately rejects—this anti-paternalism argument against government anti-obesity policies. It argues that government intervention in the food industry for the purpose of stemming the American obesity epidemic is justified and survives paternalistic objections to the contrary. This Article begins by briefly outlining the nature, severity, and causes of the obesity epidemic. It considers what can be done about the problem, finding that only government intervention is capable of effectively combating the crisis. It also outlines several types of potentially successful government anti-obesity strategies. Finally, it considers the primary topic of this Article: whether government anti-obesity policies constitute unjustified …


Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai Jan 2012

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …