Breaking News

Cetero, FDA Reach Final Resolution

FDA to accept some studies, require reanalysis for others

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Cetero Research and the FDA have reached a final resolution regarding studies the company conducted in its Houston bioanalytical lab between April 1, 2005 and June 15, 2010. The FDA has decided to accept studies performed between September 1, 2009 and June 15, 2010 for submission and review without reanalysis or further audit, and studies performed between March 1, 2008 and August 31, 2009, if accompanied by an independent third-party data integrity audit. In addition, studies that were previou...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters