FDA is Developing a Standardized Format for REMS

Did You Know?

Drug companies know how difficult it can be to develop a solid risk evaluation and mitigation strategy (REMS). In fact, the process can be so difficult that even those assigned to develop the strategy spend much of their time confused about what it is that the FDA wants/requires in a REMS.

The FDA therefore is developing a new standardized format for REMS. The structure of the new framework should be easier to understand and should allow professionals access to a more consistent set of "instructions."