Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program
Open Access
- 7 February 2007
- journal article
- research article
- Published by American Medical Association (AMA) in JAMA
- Vol. 297 (5) , 480-488
- https://doi.org/10.1001/jama.297.5.480
Abstract
Historically, only 25% of approved drugs marketed in the United States have sufficient pediatric data to support approval of product labeling by the US Food and Drug Administration (FDA) for dosing, safety, or efficacy in children.1 Inadequate dosing and safety information places children at risk for adverse events and denies them potential therapeutic benefits.2,3Keywords
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