In its Federal Register announcement, CBER stated that the software is for voluntary use and is intended to assist users with the submission of adverse events to FDA by ensuring the submission contains the minimum regulatory requirements for the Agency to conduct a comprehensive review. CBER also noted that “the VAERS eSubmitter program will help to improve the consistency, quality, and completeness of ICSR submissions and make the submission and review process more user-friendly for those required to report postmarketing adverse events for human vaccine products.”
Direct database to database submission through the Electronic Submissions Gateway (ESG)
Submission of safety reports through the VAERS eSubmitter program as described on the CBER eSubmitter Web page
It is recent announcement, FDA stated that applicants can choose either of the options listed above when electronically submitting ICSRs and ICSR attachments to VAERS.
“The ICSR eSubmitter software is a government-issued software provided in support of the Government Paperwork Elimination Act of 1998 (44 U.S.C. 3504). As users of the eSubmitter software, applicants and others required to report postmarketing adverse events are not required to perform their own file validation process.”
Additional information regarding the regulatory requirements for the preparation and submission of ICSRs and ICSR attachments can be found on CBER’s eSubmitter web page.