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 previously submitted as part of an approved or pending application will need verification of data integrity by an independent third-party audit. For studies performed between April 1, 2005 and February 28, 2008 that were previously submitted as part of an approved or pending application, or studies that will be submitted as part of a new application, will need complete reanalysis 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, chief executive officer 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 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 towards accomplishing that goal. State-of-the-art systems have been established to the satisfaction of the FDA and Cetero that verify the integrity of study data and allow us to set the gold standard for regulatory compliance.”