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GlaxoSmithKline receives FDA warning letter on regulatory reporting

-CNN


04/08/2008- GlaxoSmithKline (NYSE:GSK) Plc., said it has received a warning letter from the Food and Drug Administration, which points to failures in periodic reports to the agency about its troubled Avandia diabetes product.

The letter was sent after a routine audit of GSK's reporting processes last year which noted omissions from the reports related to Avandia. The reports included the start and progress of clinical trials and the data summaries, company said.

GSK said that it is committed to tightening up its procedures and that the FDA acknowledges that at least part of the omitted information had been submitted to the agency in other forms.

 


If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Avandia's side effects, a possible Avandia class action lawsuit, or any other type of Avandia litigation.
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