![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Wants Sponsors to Flag Real-World Evidence
FDA Wants Sponsors to Flag Real-World Evidence
The FDA may start accepting real-world evidence in support of device applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said.
Sponsors should say in their cover letters whether they hope to use real-world evidence to support safety or efficacy, to change a label, or to comply with a post-marketing requirement, the FDA said in a new draft guidance.
The guidance draws a line between real-world data—information about patients’ health status or healthcare delivery “routinely collected from a variety of sources,” including electronic health records, medical claims or billing data—and clinical evidence from analysis of real-world data.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct