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- Title
Peer-reviewed publication of clinical trials completed for pediatric exclusivity.
- Authors
Benjamin, Daniel K, Jr; Smith, Philip Brian; Murphy, M Dianne; Roberts, Rosemary; Mathis, Lisa; Avant, Debbie; Califf, Robert M; Li, Jennifer S
- Abstract
Much of pediatric drug use is off-label because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children. In 1997, Congress authorized the FDA to grant extensions of marketing rights known as "pediatric exclusivity" if FDA-requested pediatric trials were conducted. As a result, there have been over 100 product labeling changes. The publication status of studies completed for pediatric exclusivity has not been evaluated.
- Publication
JAMA, 2006, Vol 296, Issue 10, p1266
- ISSN
1538-3598
- Publication type
Journal Article
- DOI
10.1001/jama.296.10.1266