Posted by Michael Wonder on 23 Dec 2022
FDA’s new real world evidence program offers early agency feedback
21 December 2022 - The US FDA is aiming to improve the quality of real world evidence used in regulatory submissions through a new program offering early agency meetings – before full protocol development or study initiation – for sponsors using RWE in medical product development.
The Advancing RWE Program, first announced in October 2022, will provide a small number of sponsors with early, iterative feedback on real world evidence based proposals that are intended to support new labelling claims or to satisfy post-approval study requirements, according to the FDA.
