Partner and co-chair of the life sciences practice Gregory Levine (Washington, D.C.), health care partner Mark Barnes (Boston) and health care associate David Peloquin (Boston) authored an Aug. 11 Law360 “Expert Analysis” article on the U.S. Food and Drug Administration’s (FDA) new informed consent guidance for certain minimal risk research.
The article outlines the new FDA policy on waiver of informed consent for institutional review boards monitoring clinical investigations and provides advice for medical companies and institutions conducting FDA-regulated research.
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