FDA briefing document for Avandia panel meeting reveals split within agency
This article was originally published in Scrip
Executive Summary
In the 765-page briefing book prepared by the staff of the US FDA for the 13-14 July advisory committee meeting to discuss the safety profile of GlaxoSmithKline's blockbuster diabetes drug, Avandia (rosiglitazone), there are no firm recommendations to guide the discussion. In a session with reporters on 8 July, Dr Janet Woodcock, director of the agency's Center for Drug Development and Research (CDER), said this was because "there is not complete unanimity within the FDA".