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...

Descripción completa

Detalles Bibliográficos
Autores principales: Christiansen, Helle, De Bruin, Marie L., Frokjaer, Sven, Hallgreen, Christine E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Research Article
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

Internet

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

Ejemplares similares