Cover of Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report

Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report

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Washington (DC): National Academies Press (US); .
Copyright 2010 by the National Academy of Sciences. All rights reserved.
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The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety. This report outlines when and how the FDA should conduct clinical trials to protect the public's health and the health of trial participants.