• 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...
  • Regulatory NewsRegulatory News

    EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO

    The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs. The review of the CRO by EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data from studies conducted at two sites between June 2012 and June 2016 “are un...
  • Regulatory NewsRegulatory News

    FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable

    Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...
  • Feature ArticlesFeature Articles

    Considerations for Clinical Research Outsourcing in Effective Multinational Clinical Studies of Medical Devices

    It is no secret that the commercialization of medical devices presents numerous regulatory challenges. The decision to embark on a multinational clinical study must be undertaken with a significant amount of due diligence and market analysis. Companies large and small typically consider varying levels of outsourcing in their quest for efficient execution of a clinical study. The use of or dependence upon a contract research organization (CRO) is virtually guaranteed in to...
  • 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...
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    A Closer Look at Strategic Alliances Between Drugmakers and CROs

    Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. Strategic alliances represent the highest level of integration between pharmaceutical companies...