CBER ICSR Implementation
CBER is implementing the updated ICH E2B(R3) specification to support electronic submission of vaccine Individual Case Safety Reports (ICSR)s to the Vaccine Adverse Event Reporting System (VAERS). Industry participants interested in conducting pilot testing should submit a request to: CBER_eSubmitter_program@fda.hhs.gov to register.
To assist industry with preparing for vaccine electronic submissions, the following resources are available:
FDA ICH E2B(R3) Guidance Webpage: http://www.fda.gov/Drugs/GuidanceComplianceRegulatory
- FINAL DRAFT_FDA_E2B_R3_RegionalGuide010814*
*Note: this document is considered an informal working document to help inform VAERS pilot testing. FDA will issue notice and process description for formal public consultation and comments in the Federal Register.