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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Bibliografske podrobnosti
Main Authors: Arnardottir, Arna H, Haaijer-Ruskamp, Flora M, Straus, Sabine M J, Eichler, Hans-Georg, de Graeff, Pieter A, Mol, Peter G M
Format: Artigo
Jezik:Inglês
Izdano: Blackwell Science Inc 2011
Teme:
Drug Safety
Online dostop: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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