Meeting Announcement – AVANDIA

Posted by on June 3, 2013

June 5-6, 2013 8:00 a.m. to 5:00 p.m.: Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

 Where: FDA White Oak Campus

             Building 31 – The Great Room (Rm. 1503)

             White Oak Conference Center

             10903 New Hampshire Avenue Silver Spring, MD


This FDA AdComm meeting will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Please click HERE for the current roster of the Endocrinologic and Metabolic Drugs Advisory Committee.

Click HERE to view the FDA materials associated with this meeting.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact