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The content of his proposed topics is expected to be covered by other speakers as agency staff plan to summarize the available data on the cardiovascular safety of rosiglitazone at the committee meeting, and multiple FDA speakers will address their review of the readjudication of RECORD trial based on the study reports submitted to the Agency.
FORBES: The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting
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"It was an amicable meeting and I understand exactly where the safety committee are coming from, " he said.
BBC: NEWS | UK | Wales | South West Wales | Crowd cut threat over pitch ban
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Player safety was the theme of the committee's three-day meeting in Indianapolis, with the ejection for targeting the most noticeable change fans will notice in 2013 across all NCAA divisions.
NPR: New Rule To Add Ejection For Intentional High Hit
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The decision was made at a meeting of a committee of the West Midlands Road Safety Partnership Board.
BBC: West Midlands fixed speed cameras switched off
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In preparing for the July 2010 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the FDA sought to provide the committee members with all available data relevant to the cardiovascular safety of rosiglitazone.
FORBES: The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting
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Comments during the panel meeting, however, clearly indicated that committee members were concerned about both the efficacy and safety of the drug.
FORBES: CHMP Recommends Against Approval For Mipomersen In Europe
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As you know, on September 16, 2010, FDA held a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Advisory Committee) to discuss the safety and efficacy of lorcaserin, a drug developed by Arena Pharmaceuticals, Inc. (Arena) to treat obesity.
FORBES: FDA Responds To Outraged Arena Investors