• Regulatory NewsRegulatory News

    Connecticut AG Releases Unredacted Generic Drug Price Fixing Complaint

    • 24 June 2019
    Following a court motion to unseal the unredacted complaint against 20 generic drugmakers, including Teva Pharmaceuticals, Novartis’ Sandoz and Mylan Pharmaceuticals, Connecticut Attorney General William Tong on Monday released the more than 500-page document.
  • Regulatory NewsRegulatory News

    Drugmakers Call for Changes to FDA Bioavailability Guidance

    • 24 June 2019
    Drugmakers and industry groups are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on bioavailability (BA) studies submitted as part of an investigational new drug (IND) application or new drug application (NDA).
  • Regulatory NewsRegulatory News

    Australia Preps for Medicine Ingredient Name Changes

    • 24 June 2019
    As part of a push to align the names of Australia’s medicinal ingredients with names used internationally, Australia’s Therapeutics Goods Administration (TGA) has been transitioning more than 220 ingredient names as part of a process that will last until 1 May 2020.

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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).
     
  • Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

    • 18 June 2019
    Swiss notified body (NB) QS ZÜRICH AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
     
  • 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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