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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: October 20, 2005, Public Summary

The Food and Drug Administration’s (FDA) Drug Safety Oversight Board (DSB or Board) held a meeting on October 20, 2005. The primary focus of the meeting was to discuss how the Board would perform its oversight functions. To assist the discussion, FDA staff briefed the Board on recent actions taken on emerging drug safety issues, including Adderall (amphetamine salts) and Strattera (atomoxetine). In addition, the staff briefed the Board on some important pre-decisional emerging drug safety information. The Board used these pre- and post-decisional examples to discuss, further clarify, and define their oversight and advisory responsibilities to the Center Director, including their role in establishing policies and managing the communication of important drug safety issues to Agency stakeholders.