Labeling Development: Incorporation of Safety Information

Abstract

The development of prescription drug labeling is a cumulative and evolutionary process that begins early in preclinical investigation and continues for the life of a product. The incorporation of safety data into labeling represents a key activity of labeling development. The primary focus of this presentation is on labeling development with respect to safety information through Phase III of clinical development. The regulatory requirements for commercial labeling are reviewed, and the Investigator Brochure is presented as a form of “proto-labeling.” The informational requirements of the brochure are reviewed, and for each informational area, processes by which new data are incorporated into the successive editions of the brochure are considered. Preclinical information pertinent to drug safety is discussed briefly; the treatment of clinical trials safety data is emphasized.