by Amy Dow, Leah Kendall and Lee Rosebush
February 2010
The U.S. Food and Drug Administration (“FDA”) continues to focus on clinical research activities. In this regard, FDA recently has taken two additional actions to regulate the conduct of clinical trials: (1) publishing a proposed rule updating informed consent regulations; and (2) issuing a draft guidance addressing Institutional Review Board (“IRB”) continuing review requirements. This Client Alert provides a high level summary of these recent FDA regulatory developments in the clinical research area.
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