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# Guide on Safety Reporting Standards
- URL: https://www.fdaweb.com/guide-on-safety-reporting-standards/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156560

*Federal Register* notice: FDA is making available a draft guidance entitled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The document updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” published in 2003\. It is intended is to clarify the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-14/pdf/2024-05381.pdf?ref=fdaweb.com).