FDA
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
FDA
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
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.
