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    Regulatory Harmonization Initiatives

    This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards. Introduction Government bodies, non-governmental associations and trade organizations all play a role in regulatory harmonization and convergence ...
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    Fundamentals and Global Impact of 510(k) for Medical Devices

    This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers. Introduction The expansion of the global medical device healthcare market has been evolving rapidly in the 21st century Notably, clinical chemistry analyzers and in vitro diagnostics are estimated to reach $11.7 billion and $75.1 billion respectively by 2019 and 2020. 1, 2 Despite attractive opportunitie...
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    Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada

    An overview of compliance activities applicable for drugs and biologics in the US and Canada, as well as useful tools to strengthen quality compliance programs. Responsibility for the maintenance and enhancement of public health and safety is shared by government, industry, consumers, healthcare professionals and their respective associations. Regulated parties marketing drugs and biologics have primary responsibility to ensure the safety and efficacy of any product t...
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    Writing Skills for the Regulatory Professional

    Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. Kumar has been a teacher, practitioner, innovator and researcher in the healthcare regulatory and scientific professions for 18 years. This article is an introductory overview of his upcoming book. Regulatory professionals have to write highly technical documents for a variety of audiences. These documents include clinical study reports, protoco...