FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
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...
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...
United States
The new article highlights the aspects related to the testing to be conducted in order to assess the relevant mechanical performance of bone plates and screws. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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...
