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FDA warns Actelion on adverse event reporting

This article was originally published in Scrip

Executive Summary

The US FDA has issued a warning letter to Actelion over failures in post-marketing adverse drug experience reporting requirements relating to Tracleer (bosentan), Ventavis (iloprost) and Zavasca (miglustat). The firm's deviation from standards required by statute resulted in a failure to file reports of about 3,500 deaths reported in connection with the use of Tracleer and Ventavis "without an adequate basis for not reporting them", the FDA said.



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