In a previous post I discussed the FDA’s Framework for Real World Evidence program. The latest update to this program is a draft guidance intended to encourage sponsors submitting INDs, NDAs, and BLAs that use Real World Evidence (RWE) to support a regulatory decision on safety or effectiveness to self-identify those studies that use RWE. The FDA will track these submissions and use the information to help agency personnel understand the scope and use of RWE for these decisions. The guidance provides examples of the types of submissions intended for the program and the specific information to include in the cover letter accompanying the submission. The RWE may be used for a new product approval or a labeling change submission. As always, comments will be accepted  until <date> (see the Federal Register notice for details). 

Text Copyright © 2019 Katrina Rogers