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Full-Text Articles in Law
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 …
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.