White papers

Download a complimentary white paper written by a FMD K&L professional
  • The long-awaited roll out of the enhanced drug Marketing Authorization Holder (MAH) program in China

    Lei Liu

    VP of Regulatory Affairs of FMD

    As a part of the drug evaluation and approval reform in China, the enhanced Marketing Authorization
    Holder (MAH) system is now law in China nation-wide. This law eliminates a significant hurdle for drug
    developers in registering and marketing an innovative drug in China.

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  • New Accelerated Regulatory Paths in China

    Lei Liu

     

    VP of Regulatory Affairs of FMD

    At the end of August, China’s legislature finally approved the long-awaited Drug Administration Law.
    Capping the dizzying regulatory reform since 2015, the new law codifies many of the popular provisions,
    such as the 60-day IND default approval.

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  • Critical Role of Labeling Management in Regulatory Affairs

    Andy Thornley

    PhD, Senior Regulatory Consultant

    Labelling for human healthcare products (i.e. medical devices, medicines, cosmetics,
    vitamins, and dietary supplements) is a complex, interdisciplinary function that services
    the corporate and regulator-approved prescribing information, instructions for use and
    pack information for consumers, patients and healthcare professionals, together with
    correct advertising and promotion.

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  • Artificial Intelligence for Quantitative Signal Detection Methods in Pharmacovigilance and Drug Safety

    Signal detection and risk management is an important area for pharmaceutical companies for safety surveillance and benefit-risk monitoring of approved products. Marketing Authorization Holders (MAH) are using various signal detection methods and systematic empirical assessments (i.e. quantitative methods) to identify signals.

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  • A Practical Risk-Based Approach to Computerized System Validation

    Computerized System Validation (CSV) is a process of achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by the adaptation of principles, approaches and life cycle activities within the framework of validation plans and reports & by the application of appropriate operation controls throughout the lifecycle of the system.

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  • EU MDR transition – how does it impact your organization

    This whitepaper highlights the key EU MDR regulatory changes with what organizations may need to know to ensure they are prepared and compliant with these regulations.

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  • Preparing FDA Submission Data Packages


    Dhiren Patel

    Yuguang Zhao

    M.S., Senior Vice President, Programming and Development

    Tiepu Liu

    M.D., Ph.D., President, Global Biometrics

    The implementation of electronic data standards advances FDA efforts by enabling more timely and effective regulatory reviews of submissions and their corresponding data. This white paper describes the evolution of relevant standards and provides recommendations for best practices in planning and preparing FDA submission data packages.

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  • 3 steps to outsource your drug safety program

    Alok

    Alok Gokhale

    MS, MPharm, Business Analyst

    Selecting a vendor to operate your safety program can be a daunting task. This white paper provides a stepwise procedure for choosing among the hundreds of available outsourcing partners.

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  • Risk Management Roadmap to REMS Success

    Munendra

    John D. Balian

    M.D., Board of Directors

    At the birth of the REMS era, FMD K&L Board Director John D. Balian, M.D. and colleagues outlined a vision for anticipating risk-management requirements, establishing risk-management practices, and leveraging these techniques in the effective utilization of REMS programs. Their approach to enhancing product development, approval and commercialization remain germane to optimizing safety benefits for patients to this day.

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