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
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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