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  1. FDA eSubmitter

ICSR Reporting to VAERS

CBER has launched an Individual Case Safety Report (ICSR) eSubmitter program for industry in support of FDA's Electronic Safety Reporting Rule which takes effect on June 10, 2015. The CBER ICSR eSubmitter template supports creation and submission of ICSRs and ICSR attachments based upon the content requirements of the ICH E2B(R3) Implementation Guideline and other regional requirements such as the VAERS reporting form. ICSR files created using this tool can be validated for conformance to the ISO/HL7 27953 schema and FDA CBER E2B(R3) Regional Implementation Technical Specifications Document. Request to access the CBER ICSR template should be sent to: [email protected]. For additional links to CBER ICSR guidance and technical specifications documents, refer to Regulatory Submissions in Electronic Format for Biologic Products.

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