Thursday, July 28, 2011

FDA Finds Faked Documentation At Cetero

This is a really good example of how improper documentation practices can get a company into real trouble.

Read this Reuter's release, FDA finds drug research firm faked samples, documents.

In a nutshell:

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.


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