• Regulatory NewsRegulatory News

    FDA Finalizes ICH Q&A Guideline on Drug Substance Manufacturing

    • 23 February 2018
    The US Food and Drug Administration (FDA) on Friday finalized its version of the International Council for Harmonisation's (ICH) questions and answers companion to ICH's guideline on the development and manufacture of drug substances.
  • Regulatory NewsRegulatory News

    FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds

    • 23 February 2018
    From 2007 to 2016, the US Food and Drug Administration (FDA) approved more new drugs and biologics first than its European and Swiss regulatory counterparts, according to a comparison published in the European Journal of Clinical Pharmacology.
     
  • Regulatory NewsRegulatory News

    Next-Gen Sequencing, Statistical Tools Key to Trans-Tumor Drug Development

    • 23 February 2018

    Key challenges to developing "trans-tumor" targeted therapies are outlined in an editorial in the New England Journal of Medicine published Thursday by Fabrice André, head of the predictive biomarkers and novel therapeutic strategies in oncology unit at the Institute Gustave Roussy.

  • Feature ArticlesFeature Articles

    Medical Device Reimbursement in the US

    • 23 February 2018

    This article provides an overview of the history and path for reimbursement in the US for medical devices and discusses practical approaches for medical device industry professionals to integrate reimbursement strategies into product development plans and timelines to support a company's business goals and objectives.

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