How Do You Know If A REMS Is Effective? Look At Postmarket Data, Surveys, Patient Access
US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.
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Proposal would allow stakeholders to see data on REMS goals like provider training and the US FDA’s conclusions about their effectiveness.
US FDA will take multiple factors into account when deciding whether single shared-system REMS requirement is necessary.
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.