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# Draft Guide on IND Safety Report eSubmissions
- URL: https://www.fdaweb.com/draft-guide-on-ind-safety-report-esubmissions/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145373

*Federal Register* notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.”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 to CDER or CBER for serious and unexpected suspected adverse reactions that are required under the agency’s regulations. Once finalized, the guidance will require sponsors submitting the specified IND safety reports electronically to submit the reports FDA’s Adverse Event Reporting System as structured data elements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-30/pdf/2019-23666.pdf?ref=fdaweb.com).