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# Draft Guide on REMS eSubmissions
- URL: https://www.fdaweb.com/draft-guide-on-rems-esubmissions/
- Published: 2017-09-01T12:00:00.000Z
- Updated: 2026-09-14T22:46:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139529

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM574460.pdf?ref=fdaweb.com) on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 9 379k-1(a)).” The document describes how the agency plans to implement the requirements for REMS electronic submissions. FDA says that beginning no earlier than 24 months after a final guidance is released, such submissions must be submitted electronically and in the format specified by the agency.