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
FDA
The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Aug 16, 2023
FDA
The new article provides an overview of the main points highlighted by the authority in terms of the applicable regulatory requirements and also outlines the aspects to be taken into consideration when following the applicable rules. Table of Contents The Food and...
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Aug 16, 2023
FDA
The new article highlights aspects related to the second stage of the application review process and also describes the approach to be applied when making changes to a tool after its qualification. Table of Contents The Food and Drug Administration (FDA or the...
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