Safety Monitoring of Drugs Granted Exclusivity Under the Best Pharmaceuticals for Children Act: What the FDA has Learned View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2007-08

AUTHORS

L L Mathis, S Iyasu

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. More... »

PAGES

133-134

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.clpt.6100285

DOI

http://dx.doi.org/10.1038/sj.clpt.6100285

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1050836104

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/17632537


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