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Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe
4 references·2 citing·17 second hop
Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe (2010)Conditional Approval and Approval Under E…Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs? (2009)Accelerated Approval of Cance…Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma (2008)Balancing early market access…Development trends for new cancer therapeutics and vaccines (2007)Development trends for new ca…Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003 (2005)Therapeutic innovation in the…Use of the conditional marketing authorization pathway for oncology medicines in Europe (2015)Use of the conditional market…Towards a sustainable system of drug development (2014)Towards a sustainable system …Diagnosing the decline in pharmaceutical R&D efficiency (2012)From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients (2015)Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU (2016)Efficacy, safety, and cost of new anticancer drugs (2002)Defining “Innovativeness” in Drug Development: A Systematic Review (2013)Can the pharmaceutical industry reduce attrition rates? (2004)Lessons from 60 years of pharmaceutical innovation (2009)How to improve R&D productivity: the pharmaceutical industry's grand challenge (2010)How expected outcomes, stakeholders, and institutions influence corporate social responsibility at different levels of large basic needs firms (2018)Priority medicines for Europe and the world (2004)From efficacy to equity: Literature review of decision criteria for resource allocation and healthcare decisionmaking (2012)Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012 (2014)Cardiovascular Drug Development (2015)Medicines for the Mind: Policy-Based “Pull” Incentives for Creating Breakthrough CNS Drugs (2014)Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries (2022)Collaborative approaches to anticancer drug discovery and development: a Cancer Research UK perspective (2012)
this work references cited by second hop

References

  • 2008Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma229 cited
  • 2007Development trends for new cancer therapeutics and vaccines136 cited
  • 2009Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?85 cited
  • 2005Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 200361 cited

Cited by

  • 2014Towards a sustainable system of drug development58 cited
  • 2015Use of the conditional marketing authorization pathway for oncology medicines in Europe57 cited

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