FDA reviewers say data are lacking on TIRF drug use

FDA reviewers pointed to significant data gaps for evaluating the REMS program for transmucosal immediate-release fentanyl (TIRF) drugs at a joint advisory committee meeting Aug. 3.

Participants gave "important feedback" that insufficient data exists to identify how TIRF drugs are used and track adverse events, FDA Commissioner Scott Gottlieb said in a series of tweets on Aug. 3...