Electronic adverse event reports
Executive Summary
FDA's Center for Drug Evaluation & Research expects the cost of adverse event report submissions to decrease as more are submitted electronically. "We estimate the cost of receiving a report is cut from $31 per report to $3 to $19 per report for those submitted electronically," CDER says in its "2002 Report to the Nation." In a pilot program, CDER is accepting "electronic individual case safety reports from five major drug firms"...