title: Current regulatory policies regarding pediatric indications and exclusivity.
abstract: Pediatric studies have resulted in changes in the dose of many medications given to children and an increased awareness of safety issues. An additional 6 months of pediatric exclusivity legislated under the Food and Drug Administration (FDA) Modernization Act of 1997 for pediatric studies undertaken in response to written requests from the FDA have stimulated the conduct of a large number of studies.
authors.affiliation: Center for Drug Evaluation and Research (CDER) Food and Drug Administration, Rockville, MD, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Rodriguez
authors.forename: Rosemary
authors.initials: R
authors.lastname: Roberts
authors.forename: Dianne
authors.initials: D
authors.lastname: Murphy
mesh_terms: D002648:Child; D004358:Drug Therapy / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D010372:Pediatrics / Q000331:legislation & jurisprudence / Q000592:standards*; D012449:Safety; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence