Investigator’s brochures

Abstract

All marketed drugs and biologics are sold accompanied by the package leaflet (European Union [EU]) [1] or a package insert (Japan and the United States) [2–5], documents that describe product characteristics (active and inactive ingredients, chemical structure, formula, and pharmaceutical properties), summarize all known nonclinical and clinical information, and provide guidance for dosing and administration. The contents of these ‘labels’ represent the culmination of all research and development testing and of negotiations with the health authority from whom marketing approval is requested. For a marketed product, labeling documents constitute the primary method of communication with the physician prescribing the product.