Additional safety risk to exceptionally approved drugs in Europe?
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How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study.Adaptive licensing: taking the next step in the evolution of drug approval.Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.Early market access of cancer drugs in the EU.Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.Drug development challenges and strategies to address emerging and resistant fungal pathogens.Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.Use of the conditional marketing authorization pathway for oncology medicines in Europe.Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.Post-approval safety issues with innovative drugs: a European cohort study.Registries supporting new drug applications.Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.
P2860
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P2860
Additional safety risk to exceptionally approved drugs in Europe?
description
2011 nî lūn-bûn
@nan
2011年の論文
@ja
2011年論文
@yue
2011年論文
@zh-hant
2011年論文
@zh-hk
2011年論文
@zh-mo
2011年論文
@zh-tw
2011年论文
@wuu
2011年论文
@zh
2011年论文
@zh-cn
name
Additional safety risk to exceptionally approved drugs in Europe?
@en
type
label
Additional safety risk to exceptionally approved drugs in Europe?
@en
prefLabel
Additional safety risk to exceptionally approved drugs in Europe?
@en
P2093
P2860
P1476
Additional safety risk to exceptionally approved drugs in Europe?
@en
P2093
Arna H Arnardottir
Flora M Haaijer-Ruskamp
Hans-Georg Eichler
Pieter A de Graeff
Sabine M J Straus
P2860
P304
P356
10.1111/J.1365-2125.2011.03995.X
P407
P50
P577
2011-09-01T00:00:00Z