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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
FDA-2016-D-1280
Issued by:
Guidance Issuing Office
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).

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1280.

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