• Regulatory NewsRegulatory News

    May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

    • 14 June 2019
    While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.”
     
  • Regulatory NewsRegulatory News

    FDA and BioCelerate Join Forces on Nonclinical Research

    • 13 June 2019
    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development.
     
  • Regulatory NewsRegulatory News

    FDA Warns of One Death Linked to Fecal Transplants

    • 13 June 2019
    The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT).
     
  • Regulatory NewsRegulatory News

    Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

    • 13 June 2019
    The US Food and Drug Administration (FDA) has selected Merck, IBM, KPMG and Walmart to participate in a pilot evaluating blockchain technology to enhance supply chain security, according to a joint press release from the companies.

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  • UK NB Will Not Apply for EU MDR/IVDR

    • 12 June 2019
    London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).
     
  • TÜV SÜD Becomes Second NB to be Designated Under EU MDR

    • 22 May 2019
    Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the new EU Medical Devices Regulation (MDR).
     
  • FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

    • 07 June 2019
    The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions.
     
  • FDA Approves First NDA Under Real-Time Oncology Review Pilot

    • 28 May 2019
    As the US grapples with whether Novartis’ new gene therapy for spinal muscular atrophy should cost $2.1 million, the US Food and Drug Administration (FDA) on Friday also quietly signaled that another Novartis drug would effectively kick off a new way for cancer drugs to be approved more quickly.
     
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