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Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals.

作者信息

Liu Ian T T, Reynolds Gemma, Kesselheim Aaron S, Cliff Edward R Scheffer

机构信息

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Department of Pediatrics, University of Illinois at Chicago.

出版信息

JAMA. 2025 Jul 14. doi: 10.1001/jama.2025.10726.

DOI:10.1001/jama.2025.10726
PMID:40658405
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12261111/
Abstract
摘要

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Neurodegener Dis Manag. 2024;14(6):227-239. doi: 10.1080/17582024.2024.2421738. Epub 2024 Nov 15.
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Sickle cell drug is withdrawn over safety concerns just months after rollout.镰状细胞病药物在推出仅几个月后就因安全担忧而被撤市。
BMJ. 2024 Oct 1;387:q2147. doi: 10.1136/bmj.q2147.
3
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.替代标志物与非肿瘤慢性疾病治疗的临床结局之间的关联。
JAMA. 2024 May 21;331(19):1646-1654. doi: 10.1001/jama.2024.4175.
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Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.癌症药物加速审批的临床获益和监管结果。
JAMA. 2024 May 7;331(17):1471-1479. doi: 10.1001/jama.2024.2396.
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Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022.分析美国食品和药物管理局新药和生物制剂批准情况、监管途径和审查时间，1980-2022 年。
Sci Rep. 2024 Feb 9;14(1):3325. doi: 10.1038/s41598-024-53554-7.
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Ann Intern Med. 2023 Sep;176(9):1251-1256. doi: 10.7326/M23-1073. Epub 2023 Aug 22.