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GSK Gets Warning Letter on Avandia Trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline has received a warning letter from the FDA related to reporting requirements for approved medicines. The letter follows a routine inspection of the company’s 2007 reporting processes.     The inspection revealed omissions from periodic reports to the FDA regarding its diabetes drug Avandia, such as the start and progress of clinical trials, and summaries of final data from some clinical trials. The inspection also reviewed the company’s processes for reporting indi...

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