FDA writes to Glaxo

The news making headlines is FDA writing to GlaxoSmithKline (GSK) in relation to reporting requirements for approved medicines, mainly GSKs diabetes drug Avandia. It is not totally a scolding kind of warning but it requires GSK to modify the processes related to reporting.

As seen on MedicalNewsToday website:
"The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. Beyond that, information about the start of clinical trials omitted from some reports was available through posting on clinicaltrials.gov. GSK submitted a corrected 2007 Avandia annual report to the FDA in September 2007, ahead of the FDA's updated final decision on approved labeling for Avandia in November 2007. Clinical trial results are also posted publicly to GSK's clinical trial register."

In this regard GSK is much better than some of the other multinational pharma companies that are slow in even reporting ongoing studies publicly. If you take a closer look at websites like http://clinicaltrials.gov you will be surprised to see how few clinical studies are reported from each pharma company.

For the complete news item on FDA and GSK go to : http://www.medicalnewstoday.com/articles/103859.php