FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.
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Risk Communication Advisory Committee suggests that adding the agency imprimatur to REMS materials may help distinguish it from promotional mail and ensure providers read the communications.
The agency plans to use the RE-AIM model, which looks at an intervention’s reach, effectiveness, adoption, implementation and maintenance, as the basis for guidance on evaluating whether a REMS protects patient safety without being unnecessarily restrictive and burdensome on patient access.
Initial focus of volunteer industry group of pharmaceutical risk managers is drafting publications which assess the effectiveness of Risk Evaluation and Mitigation Strategies.