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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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| Main Authors: | , , , , , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2006
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| Assuntos: | |
| Acesso em linha: | 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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