FDA
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
FDA
The new article provides additional details regarding specific aspects associated with remote regulatory assessments.
FDA
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
FDA
The new article covers some specific aspects associated with the evidential expectations for implantable devices, such as human factors, clinical performance testing, and labeling.
FDA
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
