The Processing of Adverse Reaction Reports at FDA

A new regulation for reporting adverse drug reaction (ADR) information was published by the Federal Government on February 22, 1985. The regulation changes the procedures used by pharmaceutical manufacturers to update safety information in their New Drug Applications. The regulation also forced a change in the procedures used by the Food and Drug Administration (FDA) to receive, process, evaluate, and communicate adverse reaction information. This article explains the procedures now used by FDA to process the ADR information received.