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U.S. Department of Health and Human Services

For Industry

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ICSR Reporting to VAERS

CBER has launched an eSubmitter pilot program for industry in support of FDA’s ICH E2B(R3) regional implementation. The CBER ICSR eSubmitter template supports creation of ICSRs for CBER-regulated drugs, biologics and vaccines for pilot testing. The template is based upon the content requirements of the ICH E2B(R3) Implementation Guideline and other regional requirements such as VAERS specific data elements. Test 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. For additional links to CBER ICSR guidance and technical specifications documents, refer to the Regulatory Submissions in Electronic Format for Biologic Products website at:

http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685.htm