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FDA INFORMED CONSENT WAIVER RULE EXPANSION TO PERMANENT DISABILITY STUDIES SOUGHT BY RESEARCHERS; NEED FOR SEPARATE IDEs FOR ALL PRODUCTS QUESTIONED

This article was originally published in The Gray Sheet

Executive Summary

FDA's informed consent waiver rule should be expanded to allow emergency research in situations likely to result in serious and permanent disability, the Coalition of Acute Resuscitation and Critical Care Researchers argues in Oct. 17 comments submitted to the agency.
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