FDA guidance
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting…
FDA guidance · Final · issued Mar 3, 2026
Key facts
| Title | E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports |
|---|---|
| Status | Final |
| Issue date | Mar 3, 2026 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | FDA-2024-D-0803 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents