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Articles 1 - 11 of 11
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International Regulatory Harmonization: A New Era In Prescription Drug Approval, David W. Jordan
International Regulatory Harmonization: A New Era In Prescription Drug Approval, David W. Jordan
Vanderbilt Journal of Transnational Law
Critics of the Food and Drug Administration (FDA) have asserted that the agency's process of reviewing new drugs has long been laden with inefficiency and waste and, as a result, new drugs are not made available to consumers on a timely basis. This Note considers the veracity of this claim by examining the history of prescription drug regulation in the United States and the current procedure by which new drugs are reviewed. This Note also addresses the limited extent to which the FDA has interacted with its foreign counterparts in assessing the safety and efficacy of new drugs and the …
Department Of Food And Agriculture, P. Penn, B. Reznik
Department Of Food And Agriculture, P. Penn, B. Reznik
California Regulatory Law Reporter
No abstract provided.
Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman
Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman
Michigan Law Review
This Note argues that the current voluntary intoxication defense to the intentional injury exclusion clause should be modified to allow insurers subrogation rights against insureds who commit intentional acts while voluntarily intoxicated, subject to an exception for alcoholic insureds who successfully complete alcohol treatment programs. Part I discusses the public policy concerns of victim compensation and deterrence and how they influence courts deciding between the three traditional approaches to "intent." Part II analyzes the impact of these intent standards on courts' decisions to allow a voluntary intoxication defense and concludes that the defense as currently formulated promotes victim compensation at …
Umbilical Cords: The New Drug Connection, Margaret Phillips
Umbilical Cords: The New Drug Connection, Margaret Phillips
Buffalo Law Review
No abstract provided.
Random Drug-Testing Of Public School Student Athletes: A Permissible Search Under The Fourth Amendment, Paul K. Madsen
Random Drug-Testing Of Public School Student Athletes: A Permissible Search Under The Fourth Amendment, Paul K. Madsen
Brigham Young University Education and Law Journal
No abstract provided.
Exporting United States Drug Law: An Example Of The International Legal Ramifications Of The "War On Drugs", D. Brian Boggess
Exporting United States Drug Law: An Example Of The International Legal Ramifications Of The "War On Drugs", D. Brian Boggess
BYU Law Review
No abstract provided.
Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton
Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton
RISK: Health, Safety & Environment (1990-2002)
Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.
Department Of Food And Agriculture, P. Penn, B. Reznik
Department Of Food And Agriculture, P. Penn, B. Reznik
California Regulatory Law Reporter
No abstract provided.
The Right To Refuse Antipsychotic Drug Treatment And The Supreme Court: Washington V. Harper, Jeannette Brian
The Right To Refuse Antipsychotic Drug Treatment And The Supreme Court: Washington V. Harper, Jeannette Brian
Buffalo Law Review
No abstract provided.
International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz
International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz
Michigan Journal of International Law
A wide variety of instruments and mechanisms for the regulation and control of chemicals and pesticides is already available internationally. What is missing is an analysis that attempts to systematize the different approaches, to create transparency, to define where they overlap, and to discover prospective deficiencies and shortcomings. In order to accomplish this task, this article covers legally binding rules as well as recommendations and codes - the international soft law. The overall purpose is to outline a framework for future international regulation of chemicals and pesticides and to propose an international convention as a possible solution.
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
Journal of Law and Health
The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period …