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# IND Safety Report eSubmissions Guide
- URL: https://www.fdaweb.com/ind-safety-report-esubmissions-guide/
- Published: 2024-04-01T12:00:00.000Z
- Updated: 2026-09-14T14:27:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156677

*Federal Register* notice: FDA is making available a final guidance entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports that are required under 21 CFR 312.32(c)(1)(i) for serious and unexpected suspected adverse reactions. The guidance changes the electronic submission requirements for this category of IND safety reports by requiring sponsors to submit the IND safety reports to the FDA Adverse Event Reporting System following recommendations in the guidance. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-01/pdf/2024-06736.pdf?ref=fdaweb.com).