title: Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned.
abstract: The Best Pharmaceuticals for Children Act (BPCA) was signed into law on 4 January 2002, shortly after the pediatric exclusivity provision of the Food and Drug Administration (FDA) Modernization Act expired on 1 January 2002. This Act provides six months of marketing exclusivity for a drug when a pharmaceutical company studies that drug for use in the pediatric population as requested by the FDA. Section 17 of the BPCA specifically requires that the FDA review all adverse events reported for drugs that receive pediatric exclusivity. In most of the cases, no unexpected adverse events were reported in the pediatric population; however, in some cases, this focused safety review provided information important to the safety of medication use in children.
authors.affiliation: Office of New Drugs, US Public Health Service, Silver Spring, Maryland, USA. Lisa.Mathis@fda.hhs.gov
authors.forename: L L
authors.initials: LL
authors.lastname: Mathis
authors.forename: S
authors.initials: S
authors.lastname: Iyasu
mesh_terms: D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration