Sep 14, 2023
FDA
The new article highlights the aspects related to the determination of study duration, and also to the approach to be followed in order to mitigate the risks associated with missing data. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Aug 16, 2023
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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Aug 16, 2023
Australia and Oceania
The article describes the approach to be applied when requesting that a regulatory decision be reconsidered. Table of Contents The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of healthcare products, has...
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Aug 16, 2023
Australia and Oceania
The new article highlights aspects related to the application review process and regulatory decisions the authority will make based on its assessment. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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Aug 14, 2023
Australia and Oceania
The new article addresses aspects related to the documentation to be provided by the interested party responsible for the medical device in question and also describes the way the fees associated with the application audit should be calculated. Table of Contents The...
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