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Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
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Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021 (2022)Therapeutic Value of Drugs Granted Accele…Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (2021)Regulatory and clinical conse…FDA Approval and Regulation of Pharmaceuticals, 1983-2018 (2020)FDA Approval and Regulation o…Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study (2020)Association between FDA and E…Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Assessment of the Clinical Be…Arzneiverordnungs-Report 2019 (2019)Arzneiverordnungs-Report 2019A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics (2018)A 25-Year Experience of US Fo…Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review (2017)Postapproval studies of drugs…Contradicted and Initially Stronger Effects in Highly Cited Clinical Research (2005)Using Effectiveness and Cost-effectiveness to Make Drug Coverage Decisions (2009)U.S. Government Accountability Office (2013)Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 (2020)Generating comparative evidence on new drugs and devices after approval (2020)Generating comparative evidence on new drugs and devices before approval (2020)Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13 (2017)New drugs: where did we go wrong and what can we do better? (2019)Pricing of pharmaceuticals is becoming a major challenge for health systems (2020)Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Pricing in the Market for Anticancer Drugs (2015)Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study (2015)Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis (2020)Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe (2021)Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Rapid access to innovative medicinal products while ensuring relevant health technology assessment. Position of the French National Authority for Health (2023)Trends in the approval of cancer therapies by the FDA in the twenty-first century (2023)Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval (2024)A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions (2021)How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment (2021)Cancer medicines on the WHO Model List of Essential Medicines: processes, challenges, and a way forward (2022)The Accelerated Approval Program for Cancer Drugs — Finding the Right Balance (2023)Current landscape of innovative drug development and regulatory support in China (2025)
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References

  • 2020FDA Approval and Regulation of Pharmaceuticals, 1983-2018377 cited
  • 2019Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval302 cited
  • 2018A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics298 cited
  • 2017Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review121 cited
  • 2021Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study112 cited
  • 2020Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study111 cited
  • 2019Arzneiverordnungs-Report 201986 cited

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