Part 3 of 3: Simultaneous Shared REMS Development and Operations
On October 4, 2017, REMS executives from various organizations met in New Orleans for a programagnostic forum discussing emerging trends such as observer status, waiver-granted REMS programs and simultaneous shared REMS development and operations. This three-part series details these emerging trends in the REMS landscape.
Summary
Since Risk Evaluation and Mitigation Strategies (REMS) legislation was approved a decade ago, more and more reference listed drug (RLD) products with Elements To Assure Safe Use (ETASU) REMS have faced generic introductions, necessitating shared REMS programs. In recent years, we’ve also seen major modifications emerge as an expected part of the REMS lifecycle for approved shared REMS programs. Both of these trends drive an increase in the need to conduct development and operational activities simultaneously on approved REMS programs. Regardless of the driver for simultaneous development and operations, there are notable challenges involved, which are discussed in this paper.
