Part 2 of 3: Waiver-Granted Shared REMS Programs
Part 2 of 3: Waiver-Granted Shared REMS Programs
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
In the past two years, there has been a rise in the number of FDA approved waiver-granted shared Risk Evaluation and Mitigation Strategies (REMS) programs, indicating an early trend. In this post, we explain waiver-granted REMS programs, identify the potential impact of increasing numbers of waiver-granted programs and contemplate the hurdles faced with implementation of these programs.
