FDA defends RECORD data

At a Wednesday panel meeting, senior officials at FDA pushed back on concerns that data from the RECORD trial of diabetes drug Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) were mishandled.

Thomas Marciniak, medical team leader in the Division of Cardiovascular and Renal products, accused GSK of not providing complete data to FDA reviewers and said the pharma might not have provided complete data to Duke Clinical Research Institute, the third party tasked with readjudicating RECORD. Marciniak said FDA, not GSK, should have sent the RECORD data to the researchers. ...