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To mitigate irAEs, the US prescribing information Risk Evaluation and Mitigation Strategy (REMS) for ipilimumab provides suggestions for when to withhold (Table 1) or permanently discontinue (Table 2) ipilimumab therapy based on the occurrence and severity of irAEs.
The Prescription Drug User Fee Acts of 2002 and 2007 led to development of a Risk Evaluation and Mitigation Strategy (REMS), producing the 2008 guidance for industry on evaluating cardiovascular risk of new antidiabetes therapies.
To guard against prescribing to such patients, the FDA created a "risk evaluation and mitigation strategy" for the products.
They were also provided with relevant risk evaluation and mitigation (REM) tools.
Anonymous Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modification.
The F.D.A. could instead require a manufacturer to adopt a "risk evaluation and mitigation strategy" for a drug that posed serious risks.
For realistic evaluation and mitigation of thermal loads "Interim Guidelines for Thermal Load Modeling" were developed.
It added that it was overseeing an F.D.A.-required "risk evaluation and mitigation strategy to promote the appropriate use of buprenorphine with the goal to minimize the misuse, abuse and multidose unintentional exposure of these products".
To convene a group of expert stakeholders to develop recommendations for standardizing systems for the implementation of risk evaluation and mitigation strategies (REMS).
To develop an improved risk evaluation and mitigation strategies (REMS) system for maximizing effective and safe patient medication use while minimizing burden on the health care delivery system.
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Lomitapide is only available through the JUXTAPID Risk Evaluation and Mitigation Strategy Program.
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