FDAnews Drug Daily Bulletin

CBER Reveals Electronic Reporting System for Vaccine Adverse Events

May 5, 2016

CBER has introduced an electronic reporting system designed to simplify and improve the accuracy of adverse events reports for vaccines.

The Vaccine Adverse Event Reporting System (VAERS) eSubmitter program allows manufacturers, packagers and distributors to submit individual case safety reports for vaccines electronically in addition to the existing Electronic Submissions Gateway.

A final rule requiring adverse event reporters to electronically submit post-marketing ICSRs and ICSR attachments became effective June 10, 2015.


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