
FDA Draft Guidance on Translation of GLP Study Reports: Overview
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
The article briefly overviews the European regulatory framework for clinical investigations.
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.
The new article provides additional details regarding specific aspects associated with remote regulatory assessments.