For Industry

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: CBER_eSubmitter_program@fda.hhs.govFor 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

Page Last Updated: 06/04/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.