• Feature ArticlesFeature Articles

    Regenerative Medicine Advanced Therapy Designations

    • 23 May 2018

    This article discusses recent legislative action regarding Regenerative Medicine Advanced Therapies (RMAT). The author describes the criteria RMAT candidate treatments must meet to apply for RMAT designation from the US Food and Drug Administration (FDA) and outlines the steps applicants must take to gain RMAT designation from FDA. She compares the processes and success rates for applying for and gaining RMAT designation to the processes and success rates for gaining "breakthrough therapy" designation.

  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Developing Anthrax Treatments

    • 23 May 2018
    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing drugs to protect against inhalation anthrax.
  • Regulatory NewsRegulatory News

    UK Prepping for Different Brexit Scenarios

    • 23 May 2018
    Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.”
  • Regulatory NewsRegulatory News

    Health Canada to Transition to Global Medical Device Nomenclature

    • 23 May 2018
    Health Canada announced Tuesday that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada.
  • Regulatory NewsRegulatory News

    UK Prepping for Different Brexit Scenarios

    • 23 May 2018
    Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.”
  • Regulatory NewsRegulatory News

    Health Canada to Transition to Global Medical Device Nomenclature

    • 23 May 2018
    Health Canada announced Tuesday that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada.
  • Regulatory NewsRegulatory News

    EMA Begins Public Consultation on Draft Guideline for Handling and Shipping Investigational Medicines

    • 23 May 2018
    The European Medicines Agency (EMA) on Wednesday opened for consultation a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs).

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  • FDA Goes All Out With Digital Health Regulatory Paradigm Shift

    • 26 April 2018
    From the launch of a premarket digital safety program, to the release of new policies for multi-function device products, FDA Commissioner Scott Gottlieb made a plethora of announcements at the Health Datapalooza conference Thursday.
  • FDA Withdraws Final Rule to Cut Biologics Inspections

    • 04 May 2018
    The US Food and Drug Administration (FDA) on Friday withdrew a direct final rule that would have amended the general biologics regulations on inspection time requirements and would have removed inspector requirements.
  • MHRA Reveals 5-Year Plan, Seeks Clarity Post-Brexit

    • 24 April 2018
    A new five-year corporate plan the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revealed Tuesday highlights how the agency intends to “become a real world regulator” and to “ensure a smooth EU exit under any scenario.”
  • Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 30 April 2018
    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
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