Suppr超能文献

Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics.

作者信息

Wong Alissa K, Mooghali Maryam, Ramachandran Reshma, Ross Joseph S, Wallach Joshua D

机构信息

Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

Yale Collaboration for Regulatory Rigor, Integrity and Transparency, Yale School of Medicine, New Haven, Connecticut.

出版信息

JAMA Netw Open. 2023 Aug 1;6(8):e2331753. doi: 10.1001/jamanetworkopen.2023.31753.

Abstract
摘要

相似文献

1
Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics.
JAMA Netw Open. 2023 Aug 1;6(8):e2331753. doi: 10.1001/jamanetworkopen.2023.31753.
5
The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage.
J Manag Care Spec Pharm. 2023 May;29(5):464-471. doi: 10.18553/jmcp.2023.22415. Epub 2023 Mar 29.
6
Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016.
Ther Innov Regul Sci. 2019 Nov;53(6):752-758. doi: 10.1177/2168479018812058. Epub 2018 Dec 3.
7
FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
JAMA. 2020 Jan 14;323(2):164-176. doi: 10.1001/jama.2019.20288.
8
Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
Clin Ther. 2013 Jun;35(6):808-18. doi: 10.1016/j.clinthera.2013.04.004. Epub 2013 May 28.
9
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
Clin Trials. 2021 Aug;18(4):488-499. doi: 10.1177/17407745211005044. Epub 2021 Apr 16.

引用本文的文献

2
Current landscape of innovative drug development and regulatory support in China.
Signal Transduct Target Ther. 2025 Jul 22;10(1):220. doi: 10.1038/s41392-025-02267-y.
3
Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.
JAMA Netw Open. 2024 Aug 1;7(8):e2430486. doi: 10.1001/jamanetworkopen.2024.30486.
4
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics.
JAMA. 2023 Dec 26;330(24):2392-2394. doi: 10.1001/jama.2023.21958.

本文引用的文献

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验