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- [3] Global consequences of the US FDA's accelerated approval of cancer drugs LANCET ONCOLOGY, 2022, 23 (02): : 201 - 203
- [4] Confirmatory Trials of Accelerated Approval Drugs - Will Imposing Fines Reduce Delays? NEW ENGLAND JOURNAL OF MEDICINE, 2024,
- [5] Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective obser-vational study BMJ-BRITISH MEDICAL JOURNAL, 2021, 374
- [6] Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan Therapeutic Innovation & Regulatory Science, 2024, 58 : 136 - 142
- [7] Accelerated approval scrutinized - Confirmatory phase 4 studies on new drugs languish JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (24): : 3227 - 3229
- [9] Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2023, 329 (09): : 760 - 761