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Articles 31 - 60 of 103
Full-Text Articles in Food and Drug Law
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
The Role And Mission Of The United States Food And Drug Administration: Regulator, Watchdog, Facilitator, Or "All Of The Above", Roseann Termini J.D., Anthony Knabb Didonato J.D.
The Role And Mission Of The United States Food And Drug Administration: Regulator, Watchdog, Facilitator, Or "All Of The Above", Roseann Termini J.D., Anthony Knabb Didonato J.D.
North Carolina Central University Science & Intellectual Property Law Review
No abstract provided.
Feeding The Racial Disparity In Disease: How Federal Agricultural Subsidies Contribute To A Racial Disparity In The Prevalence Of Diet Related Illness, Lawrence F. Dempsey
Feeding The Racial Disparity In Disease: How Federal Agricultural Subsidies Contribute To A Racial Disparity In The Prevalence Of Diet Related Illness, Lawrence F. Dempsey
North Carolina Central University Science & Intellectual Property Law Review
No abstract provided.
Confusion Under The Big Tent: Analysis Of The North Carolina Court's Application Of N.C.G.S. § 90-95(H)(4) To The Possiession Of Prescription Pharmaceuticals In Pill Form Containing Opium Or Opium Derivatives In State V. Ellison, Sable K. Nelson
North Carolina Central University Science & Intellectual Property Law Review
No abstract provided.
Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti
Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti
Law Faculty Publications
No abstract provided.
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Washington Law Review
This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Washington Law Review
This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …
Making Liquor Immunity Worse: Nevada's Undue Protection Of Commercial Hosts Evicting Vulnerable And Dangerous Patrons, Jeffrey W. Stempel
Making Liquor Immunity Worse: Nevada's Undue Protection Of Commercial Hosts Evicting Vulnerable And Dangerous Patrons, Jeffrey W. Stempel
Nevada Law Journal
No abstract provided.
A Case Study Of The Regulations Imposed Upon Massachusetts' Prescription Monitoring Program, Meredith Rodman
A Case Study Of The Regulations Imposed Upon Massachusetts' Prescription Monitoring Program, Meredith Rodman
Public Affairs Capstones Collection
This case study focuses on the effectiveness of the recent regulations imposed upon Massachusetts’s prescription monitoring program. Abuse and/or misuse of prescription opioids is becoming increasingly problematic within the United States and as a result many policy makers are looking for ways to combat the problem. In Massachusetts, the OxyContin and Heroin Commission was established to investigate the impact of both OxyContin and heroin on the state. The Commission delivered recommendations that eventually led the state legislature to make changes to Massachusetts’s prescription monitoring program. This study targeted five major stakeholder groups and asked a series of questions through interviews …
Christopher V. Smithkline Beecham Corporation: A Tough Pill To Swallow For Pharmaceutical Sales Representatives?, Hsuan Li
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Michigan Telecommunications & Technology Law Review
“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …
Managing Complex Water Resource Systems For Ecological Integrity: Evaluating Tradeoffs And Uncertainty, Richard Morrison
Managing Complex Water Resource Systems For Ecological Integrity: Evaluating Tradeoffs And Uncertainty, Richard Morrison
Publications
Water resource systems often contain numerous components that are intertwined or even contradictory, such as power production, water delivery, recreation, and environmental needs. This complexity makes it difficult to holistically assess management alternatives. In addition, hydro climatic and ecological uncertainties complicate efforts to evaluate the impacts of management scenarios. We need new tools that are able to inform managers and researchers of the tradeoffs or consequences associated with flow alternatives, while also explicitly incorporating sources of uncertainty. My research addresses this limitation using two modeling approaches: stochastic system dynamics modeling and Bayesian network modeling. I developed a stochastic system dynamics …
The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig
The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig
Publications
It is time to move past the concept of sustainability. The realities of the Anthropocene warrant this conclusion. They include unprecedented and irreversible rates of human-induced biodiversity loss, exponential increases in per-capita resource consumption, and global climate change. These factors combine to create an increasing likelihood of rapid, nonlinear, social and ecological regime changes. The recent failure of the Rio +20 provides an opportunity to collectively reexamine--and ultimately move past--the concept of sustainability as an environmental goal. We must face the impossibility of defining--let alone pursuing--a goal of "sustainability" in a world characterized by such extreme complexity, radical uncertainty and …
Shortsighted Response To Reverse Payments: How The Third Circuit May Cause Consumers To "Pay For The Delay" Of New Drug Development, Jude Steinniger
Shortsighted Response To Reverse Payments: How The Third Circuit May Cause Consumers To "Pay For The Delay" Of New Drug Development, Jude Steinniger
Villanova Law Review (1956 - )
This case note examines the legislation of the Hatch-Waxman Act, its purpose, and the mechanics that led to the resulting reverse payment settlements. Next it surveys the landscape of prior case law in the circuit courts, and focuses on the recent Third Circuit decision in In re K-Dur Antitrust Litigation that has rekindled the Hatch-Waxman debate. Then the note analyzes the policy concerns advanced by opposing sides of the argument and the economic fallout likely to result. Finally, it concludes with the assertion that the Supreme Court must intervene and establish the most beneficial standard of analysis for reverse payment …
Presidential Politics As A Safeguard Of Federalism: The Case Of Marijuana Legalization, David S. Schwartz
Presidential Politics As A Safeguard Of Federalism: The Case Of Marijuana Legalization, David S. Schwartz
Buffalo Law Review
No abstract provided.
Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen
Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen
Journal of Food Law & Policy
In mid-August of 2012, a group of Americans stormed the White House, demanding transparency on a subject many Americans may find surprising: beer. More specifically, Americans requested White House home brew recipes, a presidential secret until Barack Obama's administration released them on September 1, 2012. Not only does Obama enjoy a good home brew, he is also the first president to brew in the White House and even take beer on the campaign trail. However, it was the August petition that garnered home brewing national media attention.
Forging Careers In Food Law And Policy: Challenges And Opportunities For Law Schools, Allison Condra
Forging Careers In Food Law And Policy: Challenges And Opportunities For Law Schools, Allison Condra
Journal of Food Law & Policy
Food Law and Policy (FL&P) is a quickly growing field of legal practice that offers many exciting career opportunities for law students. As national awareness of food and agricultural issues increases, particularly the way laws and policies influence our food system, more law students are demanding that their law schools offer courses, internships, and clinical experiences in this field. Law schools across the country have an opportunity to satisfy this student demand, while at the same time providing students with skills and knowledge that will equip them to engage with the many complex, dynamic, and important issues related to the …
Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe
Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe
Journal of Food Law & Policy
The marketing of goods under geographical names has always been common. In addition to introducing commercial facets of wine distribution agreements, this article discusses the justifications, principles and, policies that lie behind the protection of geographical indications (GIs) for wine on an international level as well as in the Old World and, to a lesser degree, in the New World. The scope and shape of the GI system will then be scrutinized in light of its own justifications and in the light of its impact on international trade, intellectual property, and agricultural policy.
A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu
A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu
Journal of Food Law & Policy
New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …
Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez
Journal of Food Law & Policy
In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
University of Richmond Law Review
No abstract provided.
The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig
The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig
Publications
No abstract provided.
Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan
Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan
Faculty Publications
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …
Spring 2014 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law
Spring 2014 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law
Publications
No abstract provided.
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Journal Articles
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …
Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd
Cardozo Law Review
The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …
Depicting The Graphic Truth: The Heated Controversy Over Cigarette Warning Labels And The Boundaries Of First Amendment Protection, Brian Fedele
Cardozo Public Law, Policy & Ethics Journal
No abstract provided.
Failing To Warn In The Context Of Rare Side Effects, Morris Dweck
Failing To Warn In The Context Of Rare Side Effects, Morris Dweck
Cardozo Public Law, Policy & Ethics Journal
No abstract provided.
The Rise Of Transnational Private Meta-Regulators, Paul Verbruggen, Tetty Havinga
The Rise Of Transnational Private Meta-Regulators, Paul Verbruggen, Tetty Havinga
Transnational Business Governance Interactions Working Papers
In recent years scholars from various disciplines have turned their attention to transnational regimes of regulation that are chiefly developed outside state-driven frameworks. The rise of such "transnational private regulation" has also led to the emergence of private meta-regulation. The term 'meta-regulation' commonly refers to processes through which a regulatory body oversees another and sets standards for its activities or performance of regulation. In the public domain, meta-regulation has been associated with the devolution of regulatory activities by a statutory body to private actors with the view to enhance voluntary rule compliance, awareness of responsibilities among the regulated and reduce …
"Natural" Food Labeling: False Advertising And The First Amendment
"Natural" Food Labeling: False Advertising And The First Amendment
Marquette Elder's Advisor
No abstract provided.