HSA
The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.
HSA
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
Uncategorized
The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory decisions.
BfArM
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
FDA
The new article highlights the key points related to the requests, the way they should be submitted, as well as the relevant processes and procedures associated thereto.
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