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FDA (CDER)
GUIDANCE FINAL
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
Published: 3/3/2026Detected: 3/20/2026

Summary preview

Defines and standardizes post-approval safety reporting expectations for Individual Case Safety Reports (ICSRs) under the E2D(R1) framework, emphasizing consistent case processing, management, and reporting.

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safety
labeling
#ICSR
#post-approval safety
#pharmacovigilance
#case processing
#reporting standards

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