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.