• ReconRecon

    Recon: GSK Commercial Reboot; EC Clears Bayer Acquisition of Monsanto

    • 21 March 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    FDA Seeks Changes to Authorities at International Mail Facilities

    • 21 March 2018
    As part of a two-day House Energy & Commerce hearing looking at about two dozen different bills to address the US opioid epidemic, Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA), told representatives that FDA needs more authority to seize and destroy suspect packages, some of which contain illegally distributed and manufactured opioids.
  • 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.

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    • 08 March 2018
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    • 26 February 2018

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    • 26 February 2018
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