DeGette, Upton Expand Cures RWE Provisions To Include Medical Devices

In the latest version of Cures 2.0 released Tuesday morning (Nov. 16), Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) direct HHS to issue guidance on how to use real-world evidence to evaluate the safety and effectiveness of breakthrough devices, and the bill requires FDA to include patient group representatives on a to-be-established Real World Evidence Task Force. The requirements expand on the RWE provisions that were included in DeGette and Upton’s draft Cures 2.0 bill in June. The draft...