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  • Regulatory NewsRegulatory News

    Industry Proposes Changes to FDA’s FIH Expansion Cohort Guidance

    Industry and oncology groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance on first-in-human clinical trials for oncology drugs that feature multiple expansion cohorts.   The 17-page draft guidance, released in August 2018, provides recommendations to sponsors on the design and conduct of such trials, which the agency says can “expedite development by seamlessly proceeding from initial determination of a poten...
  • Regulatory NewsRegulatory News

    French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

    France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials. The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the Europe...
  • Regulatory NewsRegulatory News

    EMA Revises Guideline on First-in-Human Trials

    The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex. The  revised guideline , which is open for public consultation until 28 February 2017, is intended to further assist sponsors in the transition from non-clinical to ea...
  • Regulatory NewsRegulatory News

    EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016

    The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized. The proposed revisions come after EMA launched a review of FIH trials in late May . At the time, EMA said its review would be based largely on the findings of two investigations into the fatal trial, which was conducted by French contra...
  • Japan: English Translation of First-in-Human Studies Guidance Released

    Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is announcing the publication of an English translation of a guidance document detailing how first-in-human studies are to be conducted. The Guidance ,  Establishing Safety in First-in-Human Studies during Drug Development, provides PMDA's advice on how to facilitate "the smooth transition from non-clinical to early clinical study during the drug development process."  It applies to new chemical ...