New FDA Guidance: What Review Boards Should Do

Law360, New York (December 11, 2012, 1:36 PM EST) -- In the Federal Register is a draft guidance that provides institutional review boards (IRBs) with further instruction regarding their responsibilities to evaluate the qualifications of clinical investigators and the adequacy of research sites used in connection with clinical research. We focus on these instructions in this article.

The draft guidance also provides instruction regarding an IRB's role in assessing the need for an Investigational new drug (IND) or investigational device exemption (IDE) application. The U.S. Food and Drug Administration is accepting comments until Jan. 22, 2013,...
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