E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting o
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 Counci
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-03-04 |
| Summary | 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 gui |
| Document number | 2026-04252 |
| Official record | https://www.federalregister.gov/documents/2026/03/04/2026-04252/e2dr1-postapproval-safety-data-definitions-and-standards-for-management-and-reporting-of-individual |