Daily Archives: August 30, 2010

When Does FDA Extend a PDUFA Date?

 Today Eisai Inc. issued a press release entitled "Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate".  The company sites the reason for the extension is "a result of the agency classifying recent responses to … Continue reading

Posted in FDA Policy, Tutorial | 1 Comment