Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond

被引：0
作者：
Steven Lemery
Richard Pazdur
机构：
[1] US Food and Drug Administration,Office of Oncologic Diseases, Center for Drug Evaluation and Research
[2] US Food and Drug Administration,Oncology Center of Excellence
来源：
Nature Reviews Clinical Oncology | 2022年 / 19卷
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摘要：
In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents.
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页码：217 / 218
页数：1
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  • [2] Pazdur R(2021)Promoting inclusion of members of racial and ethnic minority groups in cancer drug development JAMA Oncol. 7 1445-1447
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