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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
2 references·11 citing·23 second hop
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References

  • 2011Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer230 cited
  • 2011Accelerated Approval of Oncology Products: The Food and Drug Administration Experience212 cited

Cited by

  • 2020Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017132 cited
  • 2019New drugs: where did we go wrong and what can we do better?130 cited
  • 2017Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015127 cited
  • 2020Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study111 cited
  • 2020Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States96 cited
  • 2020Generating comparative evidence on new drugs and devices after approval87 cited
  • 2020Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe83 cited
  • 2022Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-201983 cited
  • 2017Accelerated Approval and Expensive Drugs — A Challenging Combination81 cited
  • 2020Generating comparative evidence on new drugs and devices before approval79 cited
  • 2015

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Open innovation in early drug discovery: roadmaps and roadblocks
32 cited