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Food and Drug Law

2010

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What Is The Impact Of Liquor Licensing Laws On Portland’S Entertainment Venues? A Case Study, Will Etheridge Dec 2010

What Is The Impact Of Liquor Licensing Laws On Portland’S Entertainment Venues? A Case Study, Will Etheridge

Muskie School Capstones and Dissertations

In January 2009, Port City Music Hall in Portland, Maine was preparing to open its doors to the public for the first time. With a capacity for nearly six hundred attendees, Port City Music Hall was designed to attract national touring acts to Portland too big for the bar scene, but not suited for the Merrill Auditorium or Cumberland Civic Center. With the State Theatre still shuttered at the time, this new venue hoped to fill an important niche in the city’s creative economy, bringing a diverse array of performers that would not otherwise be able to find a viable …


Legislative And Regulatory Recommendations To Allow Home-Processing Of Low-Risk Foods In Mississippi, Harvard Law School Mississippi Delta Project Dec 2010

Legislative And Regulatory Recommendations To Allow Home-Processing Of Low-Risk Foods In Mississippi, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

With the recent growth in farmers markets and the demand for local, fresh foods there has been a push to allow individuals to produce and sell foods made in their homes. This report will explain why Mississippi should follow the trend set by over 30 states to allow in-home production and sale of certain low-risk or non-potentially hazardous foods like baked goods, jams, jellies, and dried herbs. This report will lay out current Mississippi law regarding the processing of such non-potentially hazardous foods in home kitchens; compare Mississippi law to the laws employed in other states; and make recommendations for …


Patently Obvious: A Dual Standard Solution To The Diverging Needs Of The Information Technology And Pharmaceutical Patent Industries, Andrew Moody Oct 2010

Patently Obvious: A Dual Standard Solution To The Diverging Needs Of The Information Technology And Pharmaceutical Patent Industries, Andrew Moody

Golden Gate University Law Review

This Comment proposes the use of a specifically tailored obviousness standard as a new solution to the IT and pharmaceutical patent industries' divergent needs. Part I summarizes the obviousness standard's history in patent law. Part II illustrates how the IT and pharmaceutical industries have divergent needs. Part III describes why using a single standard for the obviousness inquiry is inadequate to meet the needs of both the IT and pharmaceutical industries. Part IV illustrates why the obviousness standard needs to be specifically tailored for the IT and pharmaceutical industries. Finally, Part V concludes that a dual standard for obviousness is …


Rehabilitative Punishment And The Drug Treatment Court Movement, Richard C. Boldt Oct 2010

Rehabilitative Punishment And The Drug Treatment Court Movement, Richard C. Boldt

Richard C. Boldt

No abstract provided.


Bridging The Gap: How United States V. Munn Correctly Interprets The Legislative Intent Of Amendment 706 Addressing The Disparity Between Crack And Cocaine Offenses, Alyn Goodson Oct 2010

Bridging The Gap: How United States V. Munn Correctly Interprets The Legislative Intent Of Amendment 706 Addressing The Disparity Between Crack And Cocaine Offenses, Alyn Goodson

North Carolina Central Law Review

No abstract provided.


Foodshed Foundations: Law's Role In Shaping Our Food System's Future, Margaret Sova Mccabe Oct 2010

Foodshed Foundations: Law's Role In Shaping Our Food System's Future, Margaret Sova Mccabe

Law Faculty Scholarship

[. . .] This symposium Article analyzes how we can rethink the architecture of law based on a foodshed model to provide a greater role for local, state, and regional government in the American food system. In turn, greater roles for different levels of government may help America achieve greater efficiencies in domestic food safety, nutrition and related public health issues, sustainability, and international trade.

Americans need a greater voice in the food system. The foodshed model is a powerful vehicle that allows us to conceptualize change, allowing greater citizen participation and a more nuanced approach to food policy. The …


Confidentiality Of Alcohol And Other Drug Abuse Treatment Information For Emergency Department And Trauma Center Patients, Richard Boldt Sep 2010

Confidentiality Of Alcohol And Other Drug Abuse Treatment Information For Emergency Department And Trauma Center Patients, Richard Boldt

Richard C. Boldt

he diagnosis and treatment of alcohol and other drug (AOD) use disorders has for the most part been confined to a narrow band of the U.S. heath-care system. Recently, some hospital emergency departments and, especially, trauma centers have taken the lead in seeking to integrate AOD diagnosis and treatment through the adoption of screening and brief intervention protocols. The available data suggest that the practice of providing screening and either brief interventions or referrals for more intensive AOD treatment can significantly reduce re-injury rates. Despite these encouraging statistics, many trauma centers and emergency departments still do not provide these services …


One False Move: The History Of Organic Agriculture And Consequences Of Non-Compliance With The Governing Laws And Regulations, Sara N. Pasquinelli Aug 2010

One False Move: The History Of Organic Agriculture And Consequences Of Non-Compliance With The Governing Laws And Regulations, Sara N. Pasquinelli

Golden Gate University Environmental Law Journal

This Article provides an overview of the types of factors that may lead to the decertification of organic products, and the current regulatory scheme to evaluate and adjudicate potential violations. The underlying rationale for the enforcement of the Organic Foods Production Act of 1990 may lie in protection of the integrity of the product, as well as protection of the environmental system that is integral to its production. However, the risk factors for transitioning the U.S. food economy to a larger market share in order for organic food to reach a broader population could be an unintended disincentive. Part II …


Different Endings: Lethal Injection, Animal Euthanasia, Humane Slaughter, And Unregulated Slaugter, Jeff Welty Aug 2010

Different Endings: Lethal Injection, Animal Euthanasia, Humane Slaughter, And Unregulated Slaugter, Jeff Welty

Golden Gate University Environmental Law Journal

This Article compares the laws and regulations that govern the termination of life in several contexts: lethal injection of condemned inmates; the euthanasia of companion animals; the slaughter of farmed animals covered by the Humane Methods of Slaughter Act; and the slaughter of farmed and other animals not covered by the Act.


A Conflict By Any Other Name Would Smell As Foul: A Comment On The Appointment Of A Vice-President Of Pfizer To The Cihr Governing Council, Jocelyn Downie Jul 2010

A Conflict By Any Other Name Would Smell As Foul: A Comment On The Appointment Of A Vice-President Of Pfizer To The Cihr Governing Council, Jocelyn Downie

Articles, Book Chapters, & Popular Press

If one had to pick the pharmaceutical company most associated with unethical and illegal conduct this past year, it would likely be Pfizer. So it seems reasonable to respond with disbelief and outrage to the federal government’s October 5, 2009 appointment of Dr. Bernard Prigent – Vice President, Medical Director and registered lobbyist for Pfizer Canada – to the Canadian Institutes of Health Research Governing Council (CIHR GC). This is the body that sets the strategic direction for most federally funded health research in Canada. A senior executive from a for-profit pharmaceutical company should not be given a seat at …


An Evaluation Of Lead In Imported Candies Within Clark County, Nevada, Usa, Lee Reuben Ibarra May 2010

An Evaluation Of Lead In Imported Candies Within Clark County, Nevada, Usa, Lee Reuben Ibarra

UNLV Theses, Dissertations, Professional Papers, and Capstones

Imported candies from Latin America pose a danger to children because of the potential for those candies to contain harmful levels of lead. This study sought to identify characteristics of imported candies that typically display higher concentrations of lead. This study also explored the Integrated Exposure Uptake Biokinetic model developed by the EPA. Using lead exposure data specific to Clark County, Nevada, the IEUBK model was used to estimate the amounts of candy a child would have to consume in order to raise his blood lead level to over 10µg/dL (the federal allowable limit).

The results showed that candies with …


Water Law In The Western United States, Susan Kelly Apr 2010

Water Law In The Western United States, Susan Kelly

Publications

No abstract provided.


A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider Apr 2010

A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider

William & Mary Environmental Law and Policy Review

American agricultural policy has evolved from its early focus on agricultural development and expansion to its current focus on economic and political support for the agricultural sector. Agricultural law as a discipline has tracked this policy, with agricultural law scholars debating the origins and the validity of the special treatment of agriculture under the law. This article reviews these debates and calls for a reconsideration of agricultural law and policy to address the unique aspects of agricultural production, the fragility of the environment, and the fundamental need for healthy food. Transforming the special law of agriculture to a new more …


Colorado's Instream Flow Program: History And Current Activities, The Colorado Water Conservation Board Mar 2010

Colorado's Instream Flow Program: History And Current Activities, The Colorado Water Conservation Board

Publications

No abstract provided.


Some Municipal Programs To Develop And/Or Sustain Living Rivers In New Mexico, Claudia Borchert Mar 2010

Some Municipal Programs To Develop And/Or Sustain Living Rivers In New Mexico, Claudia Borchert

Publications

No abstract provided.


Status Of New Mexico's Rivers - Existing Data Panel, Stephanie Carman, James Hogan Mar 2010

Status Of New Mexico's Rivers - Existing Data Panel, Stephanie Carman, James Hogan

Publications

No abstract provided.


Environmental Flow Issues & Science, Tom Annear Mar 2010

Environmental Flow Issues & Science, Tom Annear

Publications

No abstract provided.


Environmental Flows In Elephant Butte Irrigation District, Gary Esslinger Mar 2010

Environmental Flows In Elephant Butte Irrigation District, Gary Esslinger

Publications

No abstract provided.


Climate Change, Streamflows, And Water Management Implications In The Upper Rio Grande Watershed, Brian H. Hurd Mar 2010

Climate Change, Streamflows, And Water Management Implications In The Upper Rio Grande Watershed, Brian H. Hurd

Publications

No abstract provided.


Environmental Flows Allocation Process In Texas, Kevin Mayes Mar 2010

Environmental Flows Allocation Process In Texas, Kevin Mayes

Publications

No abstract provided.


Geomorphic Condition And Shallow Aquifers, Shann Stringer Mar 2010

Geomorphic Condition And Shallow Aquifers, Shann Stringer

Publications

No abstract provided.


Riparian Area And Upper Watershed Condition, Mary Steuver Mar 2010

Riparian Area And Upper Watershed Condition, Mary Steuver

Publications

No abstract provided.


The E-Flow Challenge In An Acequia Irrigation System With Storage - Environmental Flow Workshop, Harold Trujillo Mar 2010

The E-Flow Challenge In An Acequia Irrigation System With Storage - Environmental Flow Workshop, Harold Trujillo

Publications

No abstract provided.


A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski Feb 2010

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.


Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis Feb 2010

Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis

William & Mary Environmental Law and Policy Review

No abstract provided.


How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette Jan 2010

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …


It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü Jan 2010

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …


Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, Lesley A. Stout Jan 2010

Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, Lesley A. Stout

Kentucky Law Journal

No abstract provided.


Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn Jan 2010

Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn

Articles in Law Reviews & Other Academic Journals

Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …


The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness Jan 2010

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …