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Home » U.S. FDA Issues Guidances to Spur First-In-Human Studies
U.S. FDA Issues Guidances to Spur First-In-Human Studies
December 8, 2011
The U.S. Food and Drug Administration (FDA) proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.
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