GSK warned over reporting procedures

GlaxoSmithKline (GSK) has received a warning over the reporting requirement for approved medicine from the US Food and Drug Administration (FDA).

Following an inspection of reporting processes last year, the FDA found that there were omissions in GSK’s reporting over Avandia (rosiglitazone maleate).

It was found that data including the start and progress of certain clinical trials, as well as summaries of final data from some trials had not been reported.

“We take these findings seriously and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway. These omissions did not interfere with the timely reporting of adverse event information to the FDA,” said chief medical officer at the firm Dr Ronald Krall.

The company noted that it is “committed” to addressing the concerns raised by the FDA and is carrying out a review of its processes and reporting systems.

Avandia is a medicine designed to help treat people with type 2 diabetes through control of blood sugar levels.