The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and biologics are working properly.
This document provides guidance to industry on the assessment of risk evaluation and mitigation strategies (REMS) for prescription drug products, including biological products.
This guidance describes how to develop a REMS Assessment Plan , specifically, 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 program is meeting its risk mitigation goals. The guidance also discusses considerations for assessing the impact of REMS on patient access to the drug and its burden to the healthcare delivery system
REMS Assessment: Planning and Reporting Guidance for Industry
Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry