FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
FDA
The new article provides additional recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
FDA
The article provides an overview of the existing legal framework and also describes the key concepts related to the matter.
FDA
The article provides a brief overview of the eSTAR program and the updates thereto recently published by the US authority.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
