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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.
DSOB Meeting Summaries
Date created: February 1,
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