Additional safety risk to exceptionally approved drugs in Europe?

AIMS: Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear ‘unmet medical need’. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability o...

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Detalhes bibliográficos
Main Authors: Arnardottir, Arna H, Haaijer-Ruskamp, Flora M, Straus, Sabine M J, Eichler, Hans-Georg, de Graeff, Pieter A, Mol, Peter G M
Formato: Artigo
Idioma:Inglês
Publicado em: Blackwell Science Inc 2011
Assuntos:
Drug Safety
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3175519/
https://ncbi.nlm.nih.gov/pubmed/21501215
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2011.03995.x
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