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# IND Safety Reports eSubmission Guide
- URL: https://www.fdaweb.com/ind-safety-reports-esubmission-guide/
- Published: 2022-05-02T12:00:00.000Z
- Updated: 2026-09-14T17:42:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151721

FDA has released a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-ind-safety-reports-technical-conformance-guide?ref=fdaweb.com) entitled *Electronic Submission of IND Safety Reports Technical Conformance Guide*. The document provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to CDER/CBER. Updates to the guide since its 10/2019 release in draft form include:

- Adding information regarding data elements needed for IND safety reports from aggregate analysis
- Including provisions for submitting names of products without established names to the IND prior to electronic submissions to FDA’s Adverse Event Reporting System (FAERS)
- Updating throughout to refer to IND safety reports submitted electronically to FAERS as IND ICSRs
- Updating names of companion documents throughout