In October 2017 the Food and Drug Administration (FDA) released an updated draft guidance on the format and content of a Risk Evaluation and Mitigation Strategy (REMS) document. The release also included an updated REMS document template to be used in conjunction with the guidance. While the new REMS document contains substantially the same content described in the original 2009 FDA guidance, major changes to the format of the REMS document include:
- Reorganization of sections to clarify who is responsible for implementing the requirement, when the requirement is to be implemented, what action is required, and with what REMS material(s)
- Use of standardized text to describe requirements
- Thorough instructional text, especially focused on the REMS participant requirements of those REMS with Elements to Assure Safe Use (ETASU)
If your organization is an application holder of an approved REMS program, this new guidance will impact you. To meet the new guidance and template requirements, your current REMS document will need to be converted to the new format on the next REMS modification.
Having previous success at transitioning to the new template, MMS can help guide your organization through the transition. We have the knowledge and established processes to streamline your next REMS submission. In addition, MMS is experienced in writing all document types needed to comply with REMS requirements (e.g., REMS documents, REMS supporting documents, REMS materials, and REMS assessment surveys and reports).
At MMS, we have an entire department dedicated to writing REMS and other safety-related regulatory documents with the experience to navigate this transition. Are you ready?
Food and Drug Administration. Format and Content of a REMS Document Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
Food and Drug Administration. REMS Document Template. https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM579819.pdf