• Feature ArticlesFeature Articles

    Regulatory Operations: Leveraging eCTD Benefits

    • 21 March 2018

    This article discusses the growing requirement by health agencies for electronic Common Technical Document (eCTD) submissions rather than paper applications and explores how this move can be beneficial for organizations.

  • Regulatory NewsRegulatory News

    CMS Final Coverage Policy for NGS Cancer Assays May Boost IVD Development

    • 20 March 2018
    The Centers for Medicare and Medicaid Services’ (CMS) recent move to finalize a national coverage determination (NCD) for next generation sequencing (NGS) cancer panels underscores an emerging trend across the US expected to broaden patient access to targeted therapies.
  • Regulatory NewsRegulatory News

    Advancing Complex Trial Designs: FDA Discusses Upcoming Pilot Program

    • 20 March 2018
    Thanks to the latest Prescription Drug User Fee Act, the US Food and Drug Administration (FDA) will soon launch a pilot program on complex clinical trial designs, according to the public meeting held Tuesday on promoting the use of such designs.

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  • FDA Considers Shift on Device Quality System Regulations

    • 27 February 2018
    A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses from ISO 13485:2016 to the appropriate US regulatory requirements.
  • Philips Medical Systems Draws Lengthy FDA 483 Over Issues with Thousands of Complaints

    • 08 March 2018
    A US Food and Drug Administration (FDA) site inspection at the Philips Medical Systems manufacturing facility in Cleveland revealed inadequate handling of thousands of customer complaints, as well as numerous other GMP nonconformities, some of which led to more than 20 different recalls.
  • Regulatory Intelligence: 2017 FDA Review and Trends to Watch

    • 26 February 2018

    This article provides a variety of websites with important information on recent changes to FDA guidances and tables showing user fees, new provisions, and impact analyses. It also reviews trends and recently passed acts and provides website tools for keeping abreast of changes under the new administration.

  • FDA to Launch New Pilot Program for Orphan Designation Requests

    • 26 February 2018
    With more than 700 orphan designation requests last year, the US Food and Drug Administration (FDA) on Monday announced a new pilot program to make the request process more efficient.
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