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Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study
BACKGROUND: Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless gra...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Public Library of Science
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5832187/ https://www.ncbi.nlm.nih.gov/pubmed/29494592 http://dx.doi.org/10.1371/journal.pmed.1002520 |