A Risk Evaluation and Mitigation Strategies (REMS) is a description of the strategy for preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event. The purpose is to manage known or potential serious risks associated with a medicine to ensure that the benefits of the medicine outweigh its risks.
The REMS is not a routinely required document. The REMS is needed when the US FDA determines that additional safety measures beyond product labelling are required to ensure the benefits exceed the risks. Several factors are considered in the FDA’s REMS decision-making process with respect to whether a REMS is required and what type of REMS might be necessary (ie, what specific elements or tools should be included as part of the REMS).
The proposed REMS is submitted as 2 parts: the REMS document with REMS materials and the REMS supporting document.
- The REMS document generally must contain a timetable for submission of assessments of the REMS. Beyond that, the following sections may be included: Administrative Information, REMS Goals, REMS Requirements, REMS Materials, and Statutory Elements. Various elements may be included depending on the particular REMS requirements: a medication guide or package insert, a communication plan, “Elements to Assure Safe Use” (ETASU), and an implementation system (if REMS includes certain ETASU).
- The REMS supporting document expands on information included in the REMS document and provides additional information about the REMS, such as the rationale for and supporting information about the design, implementation, and assessment of the REMS.
The approved REMS documents and their approved REMS materials are posted on FDA’s website. REMS supporting documents are not made available on FDA’s website. The approved REMS can be updated when required. Changes to REMS will be categorized as revisions (defined as editorial changes), minor modifications, or major modifications.
The REMS document & supporting document require input from several functions. The team should identify the need for a proposed REMS and determine the REMS program.
The Emtex Medical Writers can be responsible for the document development process (eg, writing sections and coordinating the review and consolidation of comments). Furthermore, the Emtex Medical Writer can play a critical role in ensuring that all contributions from the involved functions are provided in a timely manner.