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Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
Nature Reviews Clinical Oncology ( IF 81.1 ) Pub Date : 2022-02-08 , DOI: 10.1038/s41571-022-00605-5
Steven Lemery 1 , Richard Pazdur 1, 2
Affiliation  

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.

中文翻译:

2021 年的批准:悬而未决的加速批准、药物剂量、新批准等

2021 年,FDA 肿瘤学的重点政策领域包括加速批准计划、扩大资格标准、剂量优化和患者报告的结果。FDA 继续积极批准新药和补充申请,包括三种新的嵌合抗原受体 T 细胞产品、两种抗体-药物偶联物和几种新的靶向药物。
更新日期:2022-02-09
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