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# REMS Electronic Format Guidance
- URL: https://www.fdaweb.com/rems-electronic-format-guidance/
- Published: 2021-01-04T12:00:00.000Z
- Updated: 2026-09-14T16:41:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148358

FDA has published a guidance, *Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling*, to describe the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-content-risk-evaluation-and-mitigation-strategies?ref=fdaweb.com) describes how the agency will implement the requirements for the electronic submission of REMS documents as part of submissions under NDAs, ANDAs, and some BLAs. The requirements take effect 24 months after publication of this final guidance.