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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 FDA

(800) 835-4709

(301) 827-1800

ocod@fda.hhs.gov

Consumer Affairs Branch (CBER)

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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