• Regulatory NewsRegulatory News

    Imfinzi Approved to Reduce Risk of NSCLC Progression

    • 16 February 2018
    AstraZeneca's immunotherapy Imfinzi (durvalumab) is now approved to reduce the risk of non-small-cell lung cancer (NSCLC) progression in patients with stage III disease whose tumors cannot be surgically removed after treatment with chemotherapy and radiation has caused the cancer to stop spreading.
  • Regulatory NewsRegulatory News

    FDA Quadruples Treatment Window for Clot Retrieval Device

    • 16 February 2018

    The US Food and Drug Administration (FDA) on Thursday announced it has expanded the treatment window for Concentric Medical's Trevo clot retrieval device from six to 24 hours after the onset of symptoms.

  • Regulatory NewsRegulatory News

    Experts See Promise, Risk in Relying on RWE for Medical Devices

    • 16 February 2018
    In a perspective published in the New England Journal of Medicine on Thursday, two medical device experts argue that real-world evidence (RWE) could be used to answer many questions about the safety and effectiveness of medical devices, but caution that RWE may not be appropriate for initial marketing decisions. 
  • Feature ArticlesFeature Articles

    US Apostille and Consular Legalization: Critically Important, Often Overlooked

    • 16 February 2018

    Every regulatory department must manage document requirements either internally or by engaging an outside service. This article covers the process for "legalizing" documents to sell regulated products outside of the US. A US product cannot be sold overseas without proof of the legalized document.

  • Regulatory NewsRegulatory News

    Gottlieb Outlines FY 2019 Budget Goals

    • 14 February 2018
    President Donald Trump’s budget sought a boost in funding for the US Food and Drug Administration (FDA) and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plan to pursue.
  • Regulatory NewsRegulatory News

    Pharmaceutical Co-Crystals: FDA Finalizes Guidance

    • 14 February 2018
    The US Food and Drug Administration (FDA) on Wednesday finalized a revision to its guidance on the regulatory classification of pharmaceutical co-crystals.
  • Regulatory NewsRegulatory News

    FDA Clears First Blood Test to Aid Concussion Evaluations

    • 14 February 2018
    The US Food and Drug Administration (FDA) on Wednesday signed off on the first blood test to help evaluate concussions in adults.
  • Regulatory NewsRegulatory News

    FDA Approves First Treatment for Non-Metastatic, Castration-Resistant Prostate Cancer

    • 14 February 2018
    The US Food and Drug Administration (FDA) on Wednesday approved Janssen’s Erleada (apalutamide), which is the first treatment approved for patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

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