GSK receives FDA warning letter on regulatory reporting

The letter follows a routine FDA inspection of GlaxoSmithKline’s (GSK’s) reporting processes conducted last year. The observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia (rosiglitazone maleate), such as the start and progress of clinical trials, and summaries of final data from some clinical trials.

The FDA inspection also reviewed GSK’s processes for reporting individual adverse events, which resulted in no inspection citations. The inspection found nothing to suggest that procedures for prompt reporting of adverse events were compromised.

Ronald Krall, chief medical officer at GlaxoSmithKline, said: “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.”