This guidance provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS.
This guidance provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer, more informative, and supports submission of a REMS document in Structured Product Labeling (SPL) format.
This guidance provides an overview of the types of information that should be included in a REMS document. Additional and more detailed information is provided in a separate guide, REMS Document Technical Conformance Guide, which will be updated periodically and is available on FDA’s website.
The guide can be used for drafting a REMS document for single product and shared system REMS and includes an outline for drafting a Bifurcated REMS document. This guidance and the technical conformance guide are intended to help ensure that REMS documents are clear, understandable to stakeholders, and to the extent possible, consistent in content and format, and support submission of a REMS document in SPL format.
This guidance does not provide detailed information on the format and content of other documents that are part of a REMS submission, such as the REMS materials or the REMS supporting document.
Furthermore, the guidance does not include information on how to design, implement, and evaluate a REMS or to submit revisions and modifications for a REMS.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required