• Regulatory NewsRegulatory News

    AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

    • 17 August 2018
     In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.
     
  • Regulatory NewsRegulatory News

    Microbiome-Based Products: FDA Delves Into the Unregulated

    • 17 August 2018
    As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September.
     
  • Regulatory NewsRegulatory News

    FDA and NCI Draft Pediatric Molecular Target List

    • 17 August 2018
    Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions.
     
  • ReconRecon

    Recon: Novo Nordisk Acquires Diabetes Firm Ziylo for $800M

    • 17 August 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    Device Accessories: FDA Drafts List for Reclassification to Class I

    • 17 August 2018
    The US Food and Drug Administration (FDA) on Thursday published a proposed list of medical device accessories that it believes can be reclassified to the agency's lowest risk class, Class I.
  • Regulatory NewsRegulatory News

    FDA Extends Malfunction Summary Reporting Program to Combo Products

    • 16 August 2018
    In a Thursday notice finalizing a new industry program for reporting device malfunctions, the US Food and Drug Administration (FDA) announced it has extended the eligibility of manufacturers that can chose to participate to include those with combination products.
     
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    FDA Approves First Generic Versions of EpiPen

    • 16 August 2018
    The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis) in adults and children weighing more than 33 pounds.
     

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  • Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance

    • 08 August 2018
    The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
     
  • EMA Updates on Recalled Valsartan Medicines

    • 02 August 2018
    An initial health risk assessment conducted by the European Medicines Agency (EMA) projects a hypothetical increase in cancer cases among patients who took certain medicines with a Chinese company’s active substance that was previously found to contain an impurity.
     
  • Brexit Guidance: MHRA Outlines What to Expect

    • 06 August 2018
    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Monday explained what life science companies can expect during the period that the Brexit agreement is implemented.
     
  • FDA Adds Context to Valsartan Recalls

    • 27 July 2018
    The US Food and Drug Administration (FDA) on 13 July announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). The amounts of NDMA found in the recalled batches of valsartan exceeded acceptable levels.
     
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