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Information for Vaccine Manufacturers

The US Food and Drug Administration has issued new regulations, "Postmarketing Safety Reports for Human Drug and Biologic Products; Electronic Submission Requirements", which describes requirements for electronic submission of Individual Case Safety Reports (ICSRs), ICSR attachments and periodic reports to FDA.  For more information about electronic ICSR reporting to VAERS, refer to the FDA ICSR website: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm or contact the FDA Electronic Submissions Help Desk at: esgprep@fda.hhs.gov.

Other Resources

  • Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form: PDF (62KB)