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DSaRM meeting

This article was originally published in The Tan Sheet

Executive Summary

FDA's Drug Safety & Risk Management Advisory Committee will convene Feb. 10 to "receive updates on the Drug Safety Oversight Board and agency actions" on COX-2 inhibitors, an announcement in the Federal Register Jan. 6 states. The committee, which will meet from 8 am-3 pm in Gaithersburg, Md., also will be briefed on developments in the Office of Drug Safety. Since the September 2004 market withdrawal of Merck's Vioxx, FDA has hosted a three-day meeting on use of COX-2s and other NSAIDs, as well as required a black box label statement for Pfizer's Celebrex. During a meeting in May, members of the Drug Safety committee advised that FDA make its drug safety process more transparent and consider placing drug safety experts on each of its advisory committees (1"The Tan Sheet" May 30, 2005, p. 9)...

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