Adverse event reports electronic submissions expected by spring on limited basis -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
PAPERLESS ADVERSE EVENT REPORT SUBMISSIONS EXPECTED BY SPRING from several companies under an ongoing pilot program of FDA's Adverse Event Reporting System (AERS), FDA Surveillance and Data Processing Branch Chief Bill Calvert said at the Nonprescription Drug Manufacturers Association Research & Scientific Development Conference in Washington, D.C. Nov. 13-14. Calvert's office is overseeing agency efforts to implement the transition from "paper" adverse event reports to electronic reports.