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Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act
IMPORTANCE: Many medicines prescribed to children have not been studied or formally approved for pediatric use. The Pediatric Research Equity Act of 2003 authorized the US Food and Drug Administration (FDA) to require pediatric clinical studies. OBJECTIVE: To evaluate the characteristics, completion...
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| Publicado no: | JAMA Pediatr |
|---|---|
| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Association
2018
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6583440/ https://ncbi.nlm.nih.gov/pubmed/30452498 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamapediatrics.2018.3416 |
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