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# Draft Guide on REMS eSubmissions
- URL: https://www.fdaweb.com/draft-guide-on-rems-esubmissions-2/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139542

*Federal Register* notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.” This document is mandated under the FDA Safety and Innovation Act by requiring certain submissions be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on an electronic format. It also describes how the agency plans to implement requirements for Risk Evaluation and Mitigation Strategies electronic submissions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-05/pdf/2017-18506.pdf?ref=fdaweb.com).