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Post-approval evidence generation: a shared responsibility for healthcare.

作者信息

Abbasi Ali, Rivera Donna, Curtis Lesley H, Califf Robert M

机构信息

US Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

Nat Med. 2024 Nov;30(11):3046-3049. doi: 10.1038/s41591-024-03241-x.

DOI:10.1038/s41591-024-03241-x
PMID:39271845
Abstract
摘要

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Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.项目确认：加速慢性髓性白血病药物审批。
Clin Cancer Res. 2023 Jun 13;29(12):2179-2183. doi: 10.1158/1078-0432.CCR-22-2628.
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FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial.FDA 批准概要：基于 OPTIC 试验结果修订波纳替尼的适应证和剂量方案。
Oncologist. 2022 Mar 4;27(2):149-157. doi: 10.1093/oncolo/oyab040.
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Relapse rates after elective discontinuation of anti-TNF therapy in rheumatoid arthritis: a meta-analysis and review of literature.类风湿关节炎患者选择性停用抗 TNF 治疗后的复发率：一项荟萃分析及文献综述
BMC Rheumatol. 2019 Mar 8;3:10. doi: 10.1186/s41927-019-0058-7. eCollection 2019.
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Levels of Evidence Supporting American College of Cardiology/American Heart Association and European Society of Cardiology Guidelines, 2008-2018.2008-2018 年美国心脏病学会/美国心脏协会和欧洲心脏病学会指南的证据水平。
JAMA. 2019 Mar 19;321(11):1069-1080. doi: 10.1001/jama.2019.1122.
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Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.《平价医疗法案》强制实施后癌症临床试验参与的保险拒赔情况。
Cancer. 2017 Aug 1;123(15):2893-2900. doi: 10.1002/cncr.30689. Epub 2017 Mar 23.