What you need to know
Overview papers are critical reviews of ADARs for applications on the direct pathway. They must:
- evaluate the approach taken, the evidence and the results
- review the clinical, economic, financial and usage information.
Our secretariat usually prepares overview papers.
Direct pathway ADARs may need a commentary instead if they raise complex issues, but this is rare.
For applications on the standard or expedited pathways, the critical review of your ADAR will be through a commentary.
What you need to do
You do not need to do anything in this step.
Next steps
In the next step, you will respond to the overview paper in your pre-MSAC response.
Contact
Contact your application manager or our secretariat if you have any questions.