Healthy Skepticism Library item: 10968

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Mathis LL, Iyasu S.
Safety Monitoring of Drugs Granted Exclusivity Under the Best Pharmaceuticals for Children Act: What the FDA has Learned.
Clin Pharmacol Ther 2007 Aug; 82:(2):133-4
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17632537&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

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.Clinical Pharmacology & Therapeutics (2007) 82, 133-134. doi:10.1038/sj.clpt.6100285.

Keywords:
PMID: 17632537 [PubMed - in process]