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Cetero reaches final resolution with FDA

Tuesday, April 24, 2012

Cary, N.C.-based CRO Cetero Research has reached a final resolution with the FDA over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. Following months of open collaboration between Cetero and the agency, the FDA summarized its final decision:

  • Studies performed Sept. 1, 2009 – June 15, 2010: The FDA will accept studies for submission and review without reanalysis, repeating or further audit by Cetero or a third party.
  • Studies performed March 1, 2008 – Aug. 31, 2009: The FDA will accept studies for submission and review if they are accompanied by an independent third-party data integrity audit. Studies previously submitted as part of an approved or pending application will also need verification of data integrity by an independent third-party audit.
  • Studies performed between April 1, 2005 – Feb. 28, 2008: Studies previously submitted as part of an approved or pending application, or studies to be submitted as part of a new application, will need complete reanalysis (if stable samples exist) or repeat of the study.

“We are very pleased with the final outcome of this process and want to thank each and every one of our clients, employees and the FDA for their continued diligence and professionalism as we worked through this unprecedented challenge,” said Dr. Troy W. McCall, CEO of Cetero. “This final notification marks the completion of more than eight months of successful collaboration between Cetero and various divisions within the FDA.”

“From the time Cetero discovered the incident through our own investigation and self-reported the issues directly to the FDA, to the lengthy internal investigation that followed, in which updates were regularly provided to the FDA, to the FDA review and recent final resolution, we have taken this matter very seriously,” said Dr. McCall. “We continue to support, as we always have, the FDA’s mandate to ensure the health and safety of the American public, and share a deep sense of responsibility in our important role toward accomplishing that goal.”

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