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Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?

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Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Ren, Zhaoxia Zajicek, Anne
Spatial Coverage	United States
Description	Author Affiliation: Ren Z ( Obstetric and Pediatric Pharmacology and Therapeutics Branch, The Eunice Kennedy Shriver, National Instititute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 4A01, MSC 7510, Besthesda, MD 20892-7510.); Zajicek A ( Obstetric and Pediatric Pharmacology and Therapeutics Branch, The Eunice Kennedy Shriver, National Instititute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 4A01, MSC 7510, Besthesda, MD 20892-7510. Electronic address: zajiceka@mail.nih.gov.)
Abstract	Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack of proper labels for majority of the drugs for pediatric use. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two legislative mandates to improve pediatric drug labeling. The BPCA legislation authorizes the National Institutes of Health (NIH) to implement research programs through funding clinical trials to study off-patent drugs in pediatric population. Obstetric pharmacology research gaps are in many ways similar to those in pediatrics, including off-label use of common medications, and lack of knowledge of appropriate dosing, safety, and efficacy of drugs. Much research is needed to define mechanisms of disease and drug actions in pregnant women to fill the knowledge gaps.
File Format	HTM / HTML
ISSN	01460005
Issue Number	7
Volume Number	39
e-ISSN	1558075X
Journal	Seminars in Perinatology
Language	English
Publisher	Elsevier
Publisher Date	2015-11-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Perinatology Drug Industry Legislation & Jurisprudence Drug-related Side Effects And Adverse Reactions Pediatrics Prescription Drugs Pharmacokinetics United States Food And Drug Administration Age Factors Biomedical Research Child Child, Preschool Clinical Trials As Topic Drug Labeling Government Regulation Humans Off-label Use Product Surveillance, Postmarketing United States Epidemiology Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Pediatrics, Perinatology and Child Health Obstetrics and Gynecology

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Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?

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