A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.
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
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.