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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Bibliografski detalji
Izdano u:Orphanet J Rare Dis
Glavni autori: Kreeftmeijer-Vegter, Annemarie Rosan, de Boer, Anthonius, van der Vlugt-Meijer, Roselinda H, de Vries, Peter J
Format: Artigo
Jezik:Inglês
Izdano: BioMed Central 2014
Teme:
Research
Online pristup: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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