FDA gets real

Draft guidance issued by FDA's Center for Devices and Radiological Health on the use of real-world evidence for medical devices provides industry with a guide on the agency's thinking around best practices for procuring the data and could shed light on how such data might apply to drugs as well.

According to CDRH, real-world evidence is composed of data gathered from outside traditional clinical trials, such as "pragmatic" trials, observational studies, registries, retrospective database studies, case reports, administrative and healthcare claims, or electronic health records...