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How Do You Know If A REMS Is Effective? Look At Postmarket Data, Surveys, Patient Access

 
• By Brenda Sandburg

US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.

Macro photo of tooth wheel mechanism with RISK concept related words imprinted on metal surface - Image

The US FDA advises sponsors to look at a variety of sources to determine if a Risk Evaluation and Mitigation Strategy (REMS) is meeting its goal of lessening a drug's risks, including drug utilization data, stakeholder surveys and observational and epidemiology data.

The agency describes how to develop a REMS Assessment Plan in a draft guidance released Jan. 24. The document also discusses assessing the impact of REMS on patient access...

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