Regulatory Focus™ > News Articles > FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

Posted 24 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) moved on 23 April to notify pharmaceutical companies who had contracted out bioanlytical studies to contract research organization Cetero, which FDA has accused of conducting falsified studies.

The agency conducted inspections of Cetero's Houston, Texas-based facilities twice in 2010, and "identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples."

Studies "may need to be repeated" in light of those violations, said FDA in a press statement.

FDA is advising companies who contracted work to Cetero between 1 April 2005 and 15 June 2010 that they will be required to take a range of actions:

  • studies conducted before 29 February 2008 require complete reanalysis or the study to be repeated
  • studies conducted between 1 March 2008 and 31 August 2009 must be audited by a third-party using an FDA-provided Bioanalytical Electronic Raw Data Audit Plan
  • studies conducted after 31 August 2009 will not require additional testing, reanalysis, repeating or auditing

Pharmalot reports a number of large pharmaceutical companies will need to re-conduct studies, including Israeli-based Teva Pharmaceuticals, Indian-based Ranbaxy Laboratories (now a subsidiary of Teva), Actavis and CorePharma.

"The work is mostly Phase I testing designed to show equivalency with brand-name meds. Specific drugs, however, are not mentioned, suggesting the possibility that questions may linger about the veracity of various pharmaceuticals," reports Pharmalot.

Read more:

FDA - Notification to Pharmaceutical Companies: Acceptance of third-party data integrity audit for Cetero studies conducted from March 1, 2008 to August 31, 2009

Pharmalot - Cetero Is Redoing Studies For Which Drugmakers?

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