Food and Drug Law Commons^™

Water Law In The Western United States, Susan Kelly

Publications

No abstract provided.

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

Publications

No abstract provided.

Geomorphic Condition And Shallow Aquifers, Shann Stringer

Publications

No abstract provided.

Riparian Area And Upper Watershed Condition, Mary Steuver

Publications

No abstract provided.

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

Publications

No abstract provided.

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

Publications

No abstract provided.

Environmental Flow Issues & Science, Tom Annear

Publications

No abstract provided.

Environmental Flows In Elephant Butte Irrigation District, Gary Esslinger

Publications

No abstract provided.

Environmental Flows Allocation Process In Texas, Kevin Mayes

Publications

No abstract provided.

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

Publications

No abstract provided.

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.

Regulating Tobacco Advertising And Promotion: A "Commerce Clause" Overview For State And Local Governments, Kathleen Dachille

Faculty Scholarship

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products. The new law represents the most sweeping action taken to date to reduce what remains the leading preventable cause of death in the United States.

To help you understand the potential ways in which state and local regulation of tobacco product marketing and promotion might be limited by the U.S. Constitution’s Commerce Clause, the Tobacco Control Legal Consortium, a collaborative network of …

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Law Faculty Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.

A Bitter Pill To Swallow: Canadian Drug Regulation, Michael Duncan Taylor

LLM Theses

This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion …

Volume 10 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza

UIC Law Review

No abstract provided.

Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk

Faculty Publications

This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court. …

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement with Mike …

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 …