FDA announces two draft guidances on REMS

On Thursday, the US Food and Drug Administration issued two guidances that aim to bring clarity to the assessment of risk evaluation and mitigation strategies (REMS) programs.

These guidances, “ REMS Assessment: Planning and Reporting Guidance for Industry” and “ Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry,” will assist sponsors in assessing the effectiveness of REMS programs.

The REMS Assessment draft guidance aims to increase stakeholder understanding of how to develop a REMS Assessment Plan by specifically discussing how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals.