The FDA drug approval process: focus on pediatric labeling.

Abstract

MANY HEALTHCARE professionals are not familiar with the current Food and Drug Administration (FDA) drug approval process, especially with regard to the system’s impact on pediatric patients. This column reviews the definition of pediatric labeling and its importance in the treatment of children, the history of drug regulation legislation, and the current drug approval process, proposes explanations for the deficit in pediatric labeling, and describes the steps that have been taken to correct this deficit.