共 50 条
- [1] Confirmatory Trials for Drugs Granted Conditional Approval by the Chinese National Medical Products Administration JAMA HEALTH FORUM, 2024, 5 (12):
- [2] Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021 JAMA HEALTH FORUM, 2023, 4 (03): : E230217
- [5] Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2021, 14 (03): : 806 - 811
- [6] Confirmatory Trials of Accelerated Approval Drugs - Will Imposing Fines Reduce Delays? NEW ENGLAND JOURNAL OF MEDICINE, 2024,
- [10] Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective obser-vational study BMJ-BRITISH MEDICAL JOURNAL, 2021, 374