FDA
The new article highlights the aspects related to the review process itself.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
SAHPRA
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
BfArM
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
