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  • Feature ArticlesFeature Articles

    FDA’s new integrated review template and implications for regulatory intelligence

    US Food and Drug Administration (FDA) review summaries, previously referred to as summary basis of approval documents, can serve as invaluable sources of regulatory strategy information, the details of which are not publicly available from any other source. When the FDA announced its plans to use a more streamlined approach to communicating regulatory decisions through an integrated assessment process and review document, it raised concern among those who contribute to and...
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    How to prepare for the RAC exam

    Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the leading credential for regulatory professionals in the healthcare product sector. It shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but also that you are committed to your profession. To get the credential, you must pass one of two challenging RAC exams. The average pass rate is between 40% ...
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    Advantages of developing and deploying an in-house regulatory intelligence database

    Companies with a global regulatory presence may benefit from developing an in-house regulatory intelligence database. Such a database can be customized to focus on key subjects by building content reflecting published sources and the company’s experience. Adaptable content for multiple uses can be built by the company’s local experts. The system structure must support diverse users to create, maintain, document, access, and understand the information with functional collab...
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    A multiprong approach to organizational regulatory intelligence: One company’s experience

    It is important and of value for organizations to establish a dedicated regulatory intelligence (RI) function and process with designated roles and responsibilities to support RI monitoring. The true value is realized when there is commitment and engagement across the organization to build the RI resource. This article will lay out how one process was defined for regulatory surveillance/ monitoring (which relies on communication, cross-functional team engagement, and a rob...
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    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
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    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
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    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
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    Q4 Regulatory Focus Article Series: Regulatory Intelligence

    Q4 Regulatory Focus Article Series: Regulatory Intelligence   RAPS is pleased to bring you another edition of its Regulatory Focus Article Series, comprised of timely and relevant technical articles, case studies, interviews, and research reports. These topic-focused collections are intended to benefit RAPS members responsible for healthcare-related products. Articles are developed by global subject-matter experts representing a range of regulatory responsibiliti...
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    Updated Regulatory Writing Book Now Available

    It isn’t easy to be a highly effective regulatory writer, but clear, well-written documentation is a critical part of bringing essential medicines and medical products to market. In RAPS’ newly released, Regulatory Writing: An Overview, Second Edition , aspiring and experienced writers alike will find expert guidance and advice that is easy to apply. Completely updated from the previous edition, Regulatory Writing covers content development for regulatory documents...
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    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
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    Comparison of pharmaceutical development drug regulatory pathways in the US and China

    The US has the largest pharmaceutical market in the world, as well as the highest expenditure in research and development (R&D). Right behind the US is China, in second place, as it steadily closes the gap, with increasing government investment in R&D and programs promoting the development of innovative medicines targeting the global market. To close that gap, there should be a strong R&D infrastructure, effective intellectual property protection, integration in global sta...
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    October’s Regulatory Focus: The regulatory toolbox

    Feature articles during October focused on the regulatory toolbox – the tools for routine regulatory work, from the basics for needed by newcomers to the specialty items needed by seasoned pros  working in the EU and the US. The articles collectively provide accessible, evidence-based, and (mostly) free informational tools, such as health agency guidances and best practices guidelines and advice on effective communication and career options and development.    Setting u...