Premium
Safety Monitoring of Drugs Granted Exclusivity Under the Best Pharmaceuticals for Children Act: What the FDA has Learned
Author(s) -
Mathis L L,
Iyasu S
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100285
Subject(s) - food and drug administration , clinical pharmacology , medicine , drug , drug labeling , drug approval , adverse effect , population , pharmacology , medical emergency , intensive care medicine , family medicine , environmental health
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. Clinical Pharmacology & Therapeutics (2007) 82 133–134. doi: 10.1038/sj.clpt.6100285