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FDA published guidance on the format and content of REMS documents.
On October 11, 2017, FDA published guidance providing the agency’s recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document. REMS documents establish the goals and requirements of the REMS.
Applicants drafting proposed REMS documents or wishing to convert already approved REMS documents to a new Structured Product Labeling (SPL) format will find the guidance helpful. FDA, however, stated in the guidance that the agency “does not expect applicants of an approved product subject to a REMS to submit a proposed REMS modification solely to convert their REMS document to the new format. Changing the REMS document to the new format should be done in conjunction with other REMS modifications.”
The guidance includes the types of information that should be included and includes a template, which is available on the FDA website. The agency hopes the guidance will “help ensure that REMS documents are clear, understandable to stakeholders, and to the extent possible, consistent in content and format.”