Posted by Michael Wonder on 13 Feb 2019
Industry lauds FDA RWE framework, calls for tweaks
12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma companies in comments submitted to the docket, although certain recommendations and proposals were also made.
The agency released the framework that describes its real world evidence (RWE) program last December and has received 28 comments since then. The comment period remains open, but the submitted comments already offer a look into industry’s take on the framework. Regeneron, Sanofi, Pfizer and Novartis are among those that have provided feedback alongside industry groups PhRMA and BIO.
The commenters commended FDA for posting the 40-page framework and welcomed the agency’s continued efforts to support greater use of RWE in regulatory decision-making.
