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Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US
Pediatric legislations in the European Union (EU) and the United States (US) have increased medicines approved for use in the pediatric population. Despite many similarities between these frameworks, the EU Paediatric Regulation more often provides regulators with a mandate to require pediatric drug...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Public Library of Science
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8979467/ https://www.ncbi.nlm.nih.gov/pubmed/35377911 http://dx.doi.org/10.1371/journal.pone.0266353 |