Guide on REMS Assessment: Planning and Reporting

Federal Register notice: FDA has made available a draft guidance entitled REMS Assessment: Planning and Reporting. The document describes how to develop a risk evaluation and mitigation strategy (REMS) assessment plan, specifically how the REMS program goals, objectives, and REMS design may affect the selection of metrics and data sources, which will be used to assess whether the program is meeting its risk mitigation goals. The document also discusses considerations for assessing the impact of REMS on patient access to the drug and its burden to the healthcare delivery system. Finally, it provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report. The guidance does not address the design or development of REMS; methods for designing, conducting, and reporting surveys; pharmacoepidemiologic safety studies; or other studies when used as a component of a REMS assessment. To view the notice, click here.