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# Guidance on IND Safety Report eSubmissions
- URL: https://www.fdaweb.com/guidance-on-ind-safety-report-esubmissions/
- Published: 2024-03-29T12:00:00.000Z
- Updated: 2026-09-14T14:26:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156667

FDA has posted a [final guidance](https://www.fda.gov/media/132079/download?ref=fdaweb.com) 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 for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i). The changes required under the guidance will be effective 24 months (4/1/2026) after the publication of a notice of availability in the *Federal Register*.

When it becomes effective, the document will supersede the guidance entitled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance “will not replace any requirements in the eCTD guidance other than those relating to the electronic submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance,” FDA says. “This guidance also references several technical specification documents that provide additional details about the format for electronic submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS).”