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# E-submission Guide for Expedited Safety Reports
- URL: https://www.fdaweb.com/e-submission-guide-for-expedited-safety-reports/
- Published: 2022-08-03T12:00:00.000Z
- Updated: 2026-09-14T17:54:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152435

*Federal Register* notice: FDA has made available a draft guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for the electronic submission of expedited individual case safety reports from IND-exempt bioavailability/bioequivalence studies through the FDA Adverse Event Reporting System database. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-08-03/pdf/2022-16599.pdf?ref=fdaweb.com).