CDER Offices Go Public With “Fundamental Disagreement” Over Avandia

Political pressure from FDA outsiders interested in improving drug safety oversight may have backfired, resulting in an embarrassing advisory committee meeting for the agency. The July 30 review of a cardiovascular safety signal for GlaxoSmithKline's diabetes drug Avandia became a forum to play out another controversy between the Office of New Drugs and the Office of Surveillance and Epidemiology