FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
EU
The article briefly overviews the European regulatory framework for clinical investigations.
HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
FDA
The new article provides additional details regarding specific aspects associated with remote regulatory assessments.
HSA
The article outlines the key points associated with registering healthcare products under the existing legal framework.
FDA
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
