FDA Provides Recommendations for Electronically Submitting Vaccine Postmarketing Safety Reports

Monday, August 24, 2015

Source: FDA News

Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says.

In either case, reports should include a unique case identification number to allow the agency to link initial and follow-up reports in the VAERS database.

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