# E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e2dr1-post-approval-safety-data-definitions-and-standards-for-management-and-reporting-of-individual-case-safety-reports/d300a747-e4a5-431a-aeb4-03dd8f84a959

> FDA guidance document: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. Issue date: March 13, 2024. Get complete insights and analysis.

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## Details

- Title: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-03-13
- Last Changed: 2024-03-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-0803">FDA-2024-D-0803</a>

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