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# REMS Document Format, Content Guidance
- URL: https://www.fdaweb.com/rems-document-format-content-guidance/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153463

FDA has published a guidance, *Format and Content of a REMS Document*, with recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product. The [document](https://www.fda.gov/media/77846/download?ref=fdaweb.com) 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 Protocol Labeling format.

A REMS document, FDA says, establishes the goals and requirements of the REMS. The guidance does not have detailed recommendations on the format and content of other documents that are part of a REMS submission, such as the REMS materials or the REMS supporting documents.