Posted by Michael Wonder on 08 Sep 2022
Submitting documents using real world data and real world evidence to FDA for drug and biological products
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real world evidence, this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of real world data/evidence.
This guidance does not address FDA’s substantive review of the real world data/evidence submitted as part of the Agency’s standard review process.
