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Additional safety risk to exceptionally approved drugs in Europe?

Additional safety risk to exceptionally approved drugs in Europe?

http://www.wikidata.org/entity/Q38504869

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How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009 Regulatory 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.

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P2860

Additional safety risk to exceptionally approved drugs in Europe?

http://www.wikidata.org/entity/Q38504869

description

2011 nî lūn-bûn

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2011年の論文

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J.1365-2125.2011.03995.X

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British Journal of Clinical Pharmacology

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Additional safety risk to exceptionally approved drugs in Europe?

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Arna H Arnardottir

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Flora M Haaijer-Ruskamp

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Hans-Georg Eichler

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Pieter A de Graeff

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Sabine M J Straus

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P2860

Timing of new black box warnings and withdrawals for prescription medications

Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Drug-review deadlines and safety problems.

Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics.

Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?

A call to restructure the drug development process: government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe.

Licensing drugs for diabetes.

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