Sep 14, 2023
United States
The new article highlights aspects related to the clinical studies involving devices intended to treat opioid use disorder, namely, the importance of defining the patient population the device should be used for, and also the approach to be applied with respect to...
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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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Mar 30, 2023
Asia
The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
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Mar 14, 2023
Asia
The article provides an overview of the regulatory requirements related to the content of special communications to be issued by medical device manufacturers in order to inform about the issues associated with the products they are responsible for. Table of Contents...
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