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...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:Orphanet J Rare Dis
Prif Awduron: Kreeftmeijer-Vegter, Annemarie Rosan, de Boer, Anthonius, van der Vlugt-Meijer, Roselinda H, de Vries, Peter J
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: BioMed Central 2014
Pynciau:
Research
Mynediad Ar-lein: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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