References

• 2012Diagnosing the decline in pharmaceutical R&D efficiency1,978 cited
• 2008Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma229 cited
• 2015From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients196 cited
• 2012Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies176 cited
• 2013The risks of risk aversion in drug regulation115 cited
• 2014Accelerated Access to Innovative Medicines for Patients in Need89 cited
• 2009Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?85 cited
• 2011Evaluation of Oncology Drugs at the European Medicines Agency and US Food and Drug Administration: When Differences Have an Impact on Clinical Practice79 cited
• 2013Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration75 cited
• 2011Despite Criticism Of The FDA Review Process, New Cancer Drugs Reach Patients Sooner In The United States Than In Europe67 cited
• 2010Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe58 cited

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