A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
REMS documents are required for prescription drugs, including biological drugs, as part of risk evaluation and mitigation strategies. This guidance provides an overview of the types of information that should be included in a REMS document.
As part of the Format and Content of a REMS Document guidance, applicants are provided with recommendations for drafting proposed REMS documents and converting an approved REMS document into a new, standardized format that is clearer, more informative, and supports the submission of structured product labeling (SPL) documents.
In conjunction with this guidance, FDA has developed a technical conformance guide to assist applicants with implementing the recommended format.
This Risk Evaluation and Mitigation Strategy (REMS) Document Technical Conformance Guide (Guide) provides updated, detailed instructions on the format of a REMS Document, along with standardized language that describes common REMS requirements.
The purpose of this Guide is to provide technical recommendations to applicants for the preparation of an REMS Document and to facilitate interactions between applicants and FDA personnel.