Updated REMS Document for Prescription, Biological Drug Product

A FDA guidance was published on Jan. 4 2023 that provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product and a biological drug product. A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

This guidance specifically provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer and more informative while supporting the submission of a REMS document in Structured Product Labeling format.

An overview of the types of information that should be included in a REMS document is provided in the new document, whereas additional and more detailed information is provided in a separate guide, titled REMS Document Technical Conformance Guide, which will be updated periodically 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 Bifurcated4 REMS document.

Source: U.S. FDA