Cures 2.0 Likely To Push US FDA To Further Embrace Real-World Evidence

Draft legislation, which has a good chance of getting wrapped into the next user fee bill, doesn’t give FDA any new authorities or firm mandates on real-world evidence but should nudge agency to more quickly adapt to using RWE for regulatory purposes.

two women hugging — Cures 2.0 should nudge FDA to be more comfortable using real-world evidence • Source: Alamy

The US Food and Drug Administration would be directed to increase its use of real-world evidence including letting sponsors use such data to meet post-market requirement for studies conducted as terms of accelerated approval under the new Cures 2.0 legislation.

The agency already has such authority, experts told the Pink Sheet, but the explicit directive from Congress could make a...