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...

पूर्ण विवरण

में बचाया:
ग्रंथसूची विवरण
मुख्य लेखकों: Arnardottir, Arna H, Haaijer-Ruskamp, Flora M, Straus, Sabine M J, Eichler, Hans-Georg, de Graeff, Pieter A, Mol, Peter G M
स्वरूप: Artigo
भाषा:Inglês
प्रकाशित: Blackwell Science Inc 2011
विषय:
Drug Safety
ऑनलाइन पहुंच: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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