Emotionally charged FDA memos could mean fireworks at Avandia meeting
This article was originally published in Scrip
Executive Summary
As highly charged meetings go, the two-day gathering on 5-6 June of the FDA's Endocrinologic and Metabolic Drugs (EMDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committees to review the results of a an independent readjudication of GlaxoSmithKline's controversial RECORD study of the firm's Type II diabetes drug Avandia (rosiglitazone) is expected to spark some early 4th of July fireworks, or at least, if the briefing documents are any indicator.