Thursday, July 28, 2011
Cetero Faked Documents, Claims the FDA
Drug companies that had medicines tested by a company known as Cetero Research could face product reevaluation - that news according to the FDA after it found that Cetero was faking documents and manipulating samples.The news is concerning. The FDA report states, "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during a 5 year time frame (April 1, 2005 to June 15, 2010)." Source: http://www.fda.gov/Drugs/DrugSafety/ucm265561.htm
From the FDA:
The FDA has notified Cetero Research, Houston, Texas (Cetero) of significant violations of federal regulations relating to their conduct of analytical testing of drugs before they are marketed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for pharmaceutical companies; these data are included in New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).