Zdrowie i gospodarka · 23/06/2016

FDA Releases Technical Specifications for Electronic Submission of ICSRs for Drugs and Biologics

The Food and Drug Administration (FDA) has released technical specifications for electronically submitting individual case safety reports (ICSRs) for drugs and biologics, excluding vaccines, to the FDA Adverse Event Reporting System (FAERS). This document provides guidance for industry on how to submit ICSRs and incorporate regionally controlled terminology.