GUIDANCE DOCUMENT
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports March 2026
- Docket Number:
- FDA-2024-D-0803
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” issued on March 14, 2024, and the final guidance issued September 15, 2003.
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All written comments should be identified with this document's docket number: FDA-2024-D-0803.