FDA, Gottlieb get Real about Real-world evidence
Kirkner, R.M.
Managed Care 28(3): 13-16
2019
ISSN/ISBN: 1062-3388 PMID: 30883304 Document Number: 699470
Here we are in early 2019, and how quickly and firmly the FDA and the pharmaceutical industry will embrace RWE and its raw material, real-world data (RWD), remains an open question. If that embrace is ever to get beyond gestures and lip service, the FDA will need to change its rules and culture.