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Food and Drug Law Commons

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Trends In Current Australian Agricultural Policy And Land Resource Management, Madeline Taylor 2015 Bond University

Trends In Current Australian Agricultural Policy And Land Resource Management, Madeline Taylor

Corporate Governance eJournal

Food security and the human right to food, as recognised under Article 25 of the Universal Declaration of Human Rights and Article 11 of the International Covenant of Economic, Social and Cultural Rights, are intrinsically linked. Both Articles recognize that access to agricultural land and security of tenure is essential to achieving food security. The right to food requires that each individual, alone or in concert with others, has physical and economic access at all times to adequate food or means for its procurement. Primarily, however, the right to food requires that: States refrain from taking measures that may deprive ...


Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker III 2015 University of Maryland Francis King Carey School of Law

Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii

Endnotes

No abstract provided.


Us Supreme Court To Weigh Future Of "No Harm" Class-Action Menace, David L. Wallace 2015 Herbert Smith Freehills New York LLP

Us Supreme Court To Weigh Future Of "No Harm" Class-Action Menace, David L. Wallace

David L Wallace

No abstract provided.


How Much Nature For The Consumer? Misleading Advertising, Trademark Law And The European Average Consumer Standard In The Food Sector, Andreas Wiebe 2015 Bond University

How Much Nature For The Consumer? Misleading Advertising, Trademark Law And The European Average Consumer Standard In The Food Sector, Andreas Wiebe

Corporate Governance eJournal

In Europe, the rules of unfair competition law have particular relevance for the regulation of advertising and product designation in the food sector. Apart from sector specific rules, the general framework of unfair competition law which applies is governed by the Unfair Trade Practices Directive (2008) that brought full harmonization of consumer protection laws in the unfair competition field.


Bringing Southern Bluefin Tuna Back From The Brink: Enhancing Understanding Of The Scientific Process In The Western And Central Pacific Fisheries Commission, Chris Wold, Emi Kondo, Erika Hamilton 2015 Lewis & Clark Law School

Bringing Southern Bluefin Tuna Back From The Brink: Enhancing Understanding Of The Scientific Process In The Western And Central Pacific Fisheries Commission, Chris Wold, Emi Kondo, Erika Hamilton

Boston College Environmental Affairs Law Review

The Commission of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western Pacific Ocean, or the WCPFC, manages fish stocks of significant financial and ecological value across a vast area of the Pacific Ocean. WCPFC members, however, have disagreed sharply over management measures for tuna, sharks, and other species. These disagreements have arisen due to ambiguous text in the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western Pacific Ocean regarding the roles of the Convention’s subsidiary bodies and providers of scientific advice. Some members argue that only ...


Standing Up For Industry Standing In Environmental Regulatory Challenges, Charles H. Haake, Raymond B. Ludwiszewski 2015 Gibson, Dunn & Crutcher, LLP

Standing Up For Industry Standing In Environmental Regulatory Challenges, Charles H. Haake, Raymond B. Ludwiszewski

Boston College Environmental Affairs Law Review

Article III of the U.S. Constitution limits courts to hearing only cases and controversies. To address this limitation, federal courts have developed the doctrine of standing, which requires a litigant to have suffered a cognizable injury in fact, which was caused by the challenged conduct and that will be redressable by a favorable outcome. Courts have struggled to balance these components and, in practice, different requirements have developed for meeting standing depending on the nature of the case and the type of party bringing suit. This Article explores the U.S. Court of Appeals for the District of Columbia ...


Legal Risk Management In Online Sales Of Food And Wine, Dan Svantesson 2015 dasvante_bond.edu.au

Legal Risk Management In Online Sales Of Food And Wine, Dan Svantesson

Corporate Governance eJournal

Most businesses have an online presence, but an online presence brings a legal risk exposure. The extent and type of risks that businesses expose themselves to vary depending on the industry as well as how they structure their online presence. This article examines a selection of legal risks facing businesses engaging in online sales and marketing of food and wine products. It also presents strategies for managing those risks.


The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer 2015 College of William & Mary Law School

The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer

William & Mary Business Law Review

In recent years, many states have legalized the use and sale of marijuana for medical or even recreational purposes. This has led to the booming growth of a “legal” marijuana industry. Businesses openly growing and selling marijuana products to the consuming public face some unusual legal hurdles. Significantly, although the sale of marijuana may be legal at the state level, it is still illegal under federal law. This Article explores the conflict between state and federal marijuana laws from a business entity law perspective. For example, managers owe a fiduciary duty of good faith to their businesses and equity holders ...


Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith 2015 College of William & Mary Law School

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded ...


Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith 2015 Trinity College

Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith

Senior Theses and Projects

After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth ...


Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth 2015 Boston College Law School

Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth

David A. Wirth

This paper examines the legal and policy relationship reinforcement amongst international standards for GIs, food safety standards, and other claims of quality or safety. The paper addresses those relationships within the context of international trade agreements protecting GIs, such as the 1994 TRIPS Agreement, the EU-Canada Comprehensive Economic and Trade Agreement (CETA), and the chapter on intellectual property and geographical indications in the Transatlantic Trade and Investment Partnership (TTIP) currently under negotiation. Trade agreements also discipline food safety measures and non-GI indications of quality or safety such as “organic” and “GMO-free.” Accordingly, the paper also considers the extent to which ...


Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth 2015 Boston College Law School

Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth

Boston College Law School Faculty Papers

This paper examines the legal and policy relationship reinforcement amongst international standards for GIs, food safety standards, and other claims of quality or safety. The paper addresses those relationships within the context of international trade agreements protecting GIs, such as the 1994 TRIPS Agreement, the EU-Canada Comprehensive Economic and Trade Agreement (CETA), and the chapter on intellectual property and geographical indications in the Transatlantic Trade and Investment Partnership (TTIP) currently under negotiation. Trade agreements also discipline food safety measures and non-GI indications of quality or safety such as “organic” and “GMO-free.” Accordingly, the paper also considers the extent to which ...


The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan 2015 University of Georgia School of Law

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally ...


Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance E. Bagley, Christina Tvarno 2015 Yale Law School

Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance E. Bagley, Christina Tvarno

Constance E. Bagley

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs ...


Protecting The Welfare Of Our Children For A Better Tomorrow, Aileen N. Gonzalez 2015 St. Thomas University

Protecting The Welfare Of Our Children For A Better Tomorrow, Aileen N. Gonzalez

Aileen N Gonzalez

No abstract provided.


Foie Gras Ban In California, Erica Williams Morris 2015 Golden Gate University School of Law

Foie Gras Ban In California, Erica Williams Morris

Golden Gate University Law Review

Section 25982 of the California Health and Safety Code was unsuccessfully challenged by one restaurant that served foie gras to customers for many years prior to the ban imposed by the statute. If the courts do not invalidate the statute, foie gras will be permanently banned in the state. The statute is unconstitutional, and if challenged correctly, the courts should so find. However, although foie gras production is very controversial, there are alternative methods that allow all interested parties have what they want: foie gras and happy birds.


The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan 2015 Public Citizen

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan

Hannah W Brennan

The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity ...


Great Beer, Good Intentions, Bad Law: The Unconstitutionality Of New York’S Farm Brewery License, Eric Hawkins 2015 Boston College Law School

Great Beer, Good Intentions, Bad Law: The Unconstitutionality Of New York’S Farm Brewery License, Eric Hawkins

Boston College Law Review

In January 2013, New York joined a recent legislative trend and adopted into law a farm brewery license. The law seeks to protect and promote New York’s brewery-related agricultural sectors by creating a new and cheaper “farm brewery” license that grants special privileges to licensees while mandating that they brew with in-state ingredients. This Note argues that, although well-intentioned, this legislative adaption to the craft beer revolution is a protectionist violation of the dormant Commerce Clause. In doing so, this Note provides a background to alcohol regulation in the United States, outlines the tensions these regulations have with the ...


Everything Is Presumed In Texas, Benjamin Walther 2015 Shook, Hardy & Bacon L.L.P.

Everything Is Presumed In Texas, Benjamin Walther

Benjamin Walther

As this Article will reveal, the Fifth Circuit has traditionally been loath to apply the presumption against preemption in most cases. Texas courts, on the other hand, have consistently employed a particularly strong application of the presumption to all types of preemption cases. This inconsistency between these two jurisdictions creates an incentive for forum shopping. Generally, the courts rely on a defendant’s ability to remove a case to the federal courts to counteract the plaintiff’s exclusive power to decide the forum. This ability, however, is not available to a defendant within the context of preemption cases. As such ...


Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil 2015 University of Maryland Francis King Carey School of Law

Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil

Journal of Health Care Law and Policy

The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label ...


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