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  • Regulatory NewsRegulatory News

    FDA to Withdraw Generic Drug After Company Repeatedly Fails to Resubmit Bioequivalence Data

    After the US Food and Drug Administration (FDA) discovered an abbreviated new drug application (ANDA) relied on data from a disreputable contract researcher, and after repeated attempts over five years to get the company to resubmit new data, the agency on Friday proposed to withdraw the approval for Cipla subsidiary InvaGen Pharmaceuticals’ trandolapril tablets. “The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data...
  • FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

    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...