As an evolution of this process, the agency established the Risk Evaluation and Mitigation Strategies (REMS) program in 2008.
Products can be approved with a Medication Guide only REMS, a Communication Plan REMS which incorporates a Medication Guide together with educational materials for providers or it can require Elements to Assure Safe Usage (ETASU).
There has been substantial criticism of the current REMS system from pharmaceutical companies, as well as from providers and dispensers. The FDA is moving to address some of these criticisms by trying to establish greater standardization across the system.
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The report, Risk Evaluation and Mitigation Strategies – Adaptation in an evolving system, has been written to provide insights, analysis, and support to the pharmaceutical teams working on their companys REMS. CBRs report on REMS uses both primary & secondary market research to support the analysis and insights provided.
- Overview, requirements and elements of REMS
- Current opinions and strategies
- Future outlook
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Key Reasons to Purchase
- Compare your companys REM procedures with those of other pharmaceutical companies
- Analyze the most effective ways to develop REMS programs for your products
- Understand the current FDA trends on REMS and the impact they may have on your company
- Assess the strategies that can help make REMS a competitive tool
- Determine the best practice for your REMS teams
- Benefit from industry primary research to support your key decision making with regards to your REMS procedures & strategyb
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