Reagan-Udall Annual Meeting: 4 Takeaways From US FDA Center Directors
US FDA's center directors chime in on topics such as antimicrobial drug development and public education at the 2019 Reagan-Udall annual meeting.
You may also be interested in...
CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed.
Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.
Use of historical controls and alternative study designs are allowed, but randomized control trial is preferred.