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Vaccines, Blood & Biologics
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Resources for You
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Individual Case Safety Reports (ICSR) - Specifications
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Specifications
- Acknowledgement Messages and Formats - Electronic Submissions Gateway (PDF - 96KB)
- M2 Electronic Transmission of Individual Case Safety Report Message Specification (PDF - 850KB)
- Individual Case Safety Report XML Document Type Definition Version 2.1 (PDF - 24KB)
- Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (PDF - 84KB)
- Transmitting Electronic ICSRs and ICSR Attachments on Physical Media (PDF - 28KB)
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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