The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

BACKGROUND: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment...

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Detalhes bibliográficos
Publicado no:Orphanet J Rare Dis
Main Authors: Kreeftmeijer-Vegter, Annemarie Rosan, de Boer, Anthonius, van der Vlugt-Meijer, Roselinda H, de Vries, Peter J
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2014
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4237943/
https://ncbi.nlm.nih.gov/pubmed/25091201
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-014-0120-x
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