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  • Regulatory NewsRegulatory News

    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...
  • EMA Phasing Out Follow-Up Measures

    The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them  with three categories of post-marketing commitments: Conditions in Annex II (obligations or specific obligations to fulfil post-authorization measures); Additional pharmacovigilance activities in the risk-management plan; Recommendations for further development. The old "follow-up measures" estab...