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Guidance on E-Submissions of Vaccine Safety Reports


Federal Register Notice: FDA is making available a document entitled Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines; Guidance for Industry. It provides information and recommendations on the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved BLAs, including individual case safety reports (ICSRs) and attachments to ICSRs, into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is co-sponsored by the CDC and FDA. To download this guidance, click here. To view this notice, click here.