FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products April 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2016-D-1280
• Issued by: Center for Drug Evaluation and Research

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency). This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding FDA Adverse Event Reporting System (FAERS) regional data elements that are not addressed in the International Conference on Harmonisation’s (ICH) E2B (R3) Implementation Guideline (IG) for the following FDA-regulated products:

• Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
• Prescription drug products marketed for human use without an approved application
• Nonprescription (over-the-counter) drug products marketed for human use without an approved application
• Biological products with approved biologics license applications (BLAs).

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