title: The FDA drug approval process: focus on pediatric labeling.
authors.affiliation: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
authors.forename: G L
authors.initials: GL
authors.lastname: Brummel
mesh_terms: D002648:Child; D017277:Drug Approval / Q000458:organization & administration*; D004348:Drug Labeling / Q000592:standards* / Q000639:trends; D006801:Humans; D010372:Pediatrics / Q000592:standards* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration