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Testing of New Drugs Approved From 2015 Through 2021 Under the US Pediatric Research Equity Act.

作者信息

Liu Ian T T, Hwang Thomas J, Kesselheim Aaron S

机构信息

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.

Now with Department of Pediatrics, University of Illinois at Chicago.

出版信息

JAMA. 2024 Nov 5;332(17):1482-1484. doi: 10.1001/jama.2024.18338.

DOI:10.1001/jama.2024.18338
PMID:39373993
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11581673/
Abstract
摘要

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Clinical trials for paediatric cancers under new legislation in the USA.美国新立法下针对儿童癌症的临床试验。
Lancet Child Adolesc Health. 2023 Jul;7(7):e13. doi: 10.1016/S2352-4642(23)00125-6.
2
Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.美国儿科研究公平法案下强制性儿科上市后研究的完成率和报告情况。
JAMA Pediatr. 2019 Jan 1;173(1):68-74. doi: 10.1001/jamapediatrics.2018.3416.
3
Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.新药获批时可获取的儿科药物信息:一项横断面分析。
Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):161-167. doi: 10.1002/pds.4351. Epub 2017 Nov 17.
4
Orphan products: an emerging trend in drug approvals.孤儿药:药物审批中的一种新兴趋势。
Nat Rev Drug Discov. 2010 Jan;9(1):84. doi: 10.1038/nrd2546-c1.