Sep 20, 2023
FDA
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
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Sep 20, 2023
MHRA
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
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Sep 19, 2023
MHRA
This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved. Table of Contents The Medicines and Healthcare Products Regulatory...
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Sep 18, 2023
Australia
The new article highlights the aspects related to the review procedures, and emphasizes the involvement of the administrative tribunal. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
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Sep 18, 2023
United States
The new article highlights aspects related to clinical outcomes to be used in the context of studies involving devices intended to treat opioid use disorder. In particular, the article describes in detail the change in drug use as one of the possible clinical outcomes...
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