Since 2007, when the U.S. Food and Drug Administration (FDA) began requiring REMS, there have been significant changes to the design, implementation, and evaluation of these programs.
With the constantly changing dynamics in healthcare, REMS have also had to evolve to stay effective. Today, there are over 70 approved REMS programs designed to mitigate a wide variety of risks.
As the FDA continues to refine its use of REMS, a number of trends have emerged. These include an increased emphasis on the standardization of REMS elements across programs, multi-sponsor REMS covering both innovator and generic products, and the use of multiple methods to evaluate the effectiveness of REMS.
If you are currently involved with an existing REMS program or anticipate your product needing a REMS, these trends may have implications for you.
This webinar will address:
- The evolution of REMS, including current trends and their implications;
- Shared REMS: a current hot spot of activity; and
- The evaluation of REMS using multiple measures of effectiveness.