FDA
The new article highlights the aspects related to the design of animal studies involving medical devices to be considered by the responsible parties in order to ensure the accuracy and reliability of the results.
FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
FDA
The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study
FDA
The new article highlights the aspects related to monitoring methods and associated matters.
FDA
The new article provides an overview of the existing legal framework for the translation of GLP study reports
FDA
The new article provides an overview of the regulatory framework for animal studies involving medical devices.
