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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US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.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The agency describes how to develop a REMS Assessment Plan in a draft guidance released Jan. 24.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 to the drug and its burden to the healthcare delivery system. FDA also issued a

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