Adverse Drug Reactions

GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting

Published in Health Business Week, April 25th, 2008

GlaxoSmithKline (NYSE:GSK) confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year.

The observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia(R) (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...

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Source: Health Business Week (2008-04-25)

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