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Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity

CONTEXT: 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 FDA to grant extensions of marketing rights known as “pe...

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Dettagli Bibliografici
Autori principali: Benjamin, Daniel Kelly, Smith, Philip Brian, Murphy, M. Dianne, Roberts, Rosemary, Mathis, Lisa, Avant, Debbie, Califf, Robert M, Li, Jennifer S.
Natura: Artigo
Lingua:Inglês
Pubblicazione: 2006
Soggetti:
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC2773660/
https://ncbi.nlm.nih.gov/pubmed/16968851
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.296.10.1266
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