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    FDA Reveals Vision for the Transition to ISO 13485

    • 25 September 2018
    An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.
  • Regulatory NewsRegulatory News

    Compounding: FDA Revises Insanitary Conditions Guidance, Finalizes Guidance on Radiopharmaceuticals

    • 25 September 2018
    The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance on insanitary conditions at compounding facilities and two final guidances on compounding and repackaging radiopharmaceuticals as it works to ramp up enforcement of compounders and outsourcing facilities.
  • Regulatory NewsRegulatory News

    Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

    • 25 September 2018
    Beginning 1 January 2019, drugmakers will be required to report drug shortages in Australia, the country's Therapeutic Goods Administration (TGA) announced Tuesday.
  • Regulatory NewsRegulatory News

    UK to Allow Electronic Consent Forms for Trials

    • 25 September 2018
    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will allow clinical trials of investigational medical products to use electronic signatures when obtaining consent from a patient to participate in a trial.
     
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    Feature ArticlesFeature Articles

    Complying With the new EU IVDR

    • 22 August 2018

    This article discusses processes and plans that need to be developed by In Vitro Diagnostic (IVD) companies to address the new EU In Vitro Diagnostic Regulations (IVDRs) in advance of their coming into full force in 2022.

  • Regulatory NewsRegulatory News

    UK to Allow Electronic Consent Forms for Trials

    • 25 September 2018
    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will allow clinical trials of investigational medical products to use electronic signatures when obtaining consent from a patient to participate in a trial.
     
  • Regulatory NewsRegulatory News

    FDA Warns Indian Drugmaker for CGMP Violations

    • 25 September 2018
    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Nandore, India-based Wilson Medicine for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
     
  • Regulatory NewsRegulatory News

    New Patent Database to Help Governments Procure Medicines

    • 25 September 2018
    A new online tool could help government procurement agencies better understand the global patent status of medicines, the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) announced Tuesday.
     

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FDA Reveals Vision for the Transition to ISO 13485
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An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.
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About Regulatory Focus

Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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