May 14, 2022
FDA
The article addresses the aspects related to the study duration, and also the inclusion/exclusion criteria to be considered. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
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May 9, 2022
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
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Apr 25, 2022
Asia
The new article provides additional details regarding the specific aspects covered by the scope of the new regulation on clinical trials for medical devices. Table of Contents The new regulation related to clinical trials for medical devices has been...
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Apr 21, 2022
Asia
The new article describes in detail the approach to be applied when analyzing the data deriving from clinical investigations. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
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Apr 18, 2022
Asia
The new article provides additional details regarding the new regulation on clinical trials for medical devices published recently in Turkey. In particular, the article addresses the matters related to the reports associated with clinical trials and also outlines the...
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