All Regulatory Rapporteur articles in November 2022

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    Article

    Medical Device Standards Update

    2022-10-31T14:41:00Z

     

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    Article

    Breakthrough therapy designation: From serious diseases to opioid crisis prevention

    2022-10-31T14:41:00Z

    Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...

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    Article

    The worldwide acceptance of non-legalised eCPPs

    2022-10-31T14:41:00Z

    The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...

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    Article

    The power of collaboration

    2022-10-31T14:40:00Z

    Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.

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    Article

    US FDA CDER and CBER guidance of interest

    2022-10-31T14:40:00Z

    The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...

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    Editorial

    Adapting, transforming and innovating

    2022-10-31T14:40:00Z

    For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...