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Conducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk
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November 4, 2009
Previously published on October 2009
This section overviews the legal framework for conducting clinical trials in the US and abroad for clinical trials involving Food and Drug Administration (FDA)-regulated trials and those that are launched by US entities such as academic medical centers (AMC) that are not subject to FDA regulation. Other laws that also affect certain aspects of the clinical trial implementation will also be considered. Also included in the overview is information about major regulatory guidelines set forth by international bodies such as the International Conference on the Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).
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The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
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