Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.
作者信息
Rathi Vinay K, Johnston James L, Dhruva Sanket, Ross Joseph
机构信息
Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, USA.
Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
出版信息
BMJ Surg Interv Health Technol. 2023 Feb 8;5(1):e000152. doi: 10.1136/bmjsit-2022-000152. eCollection 2023.
Abstract
摘要
相似文献
1
Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.2001年至2018年期间获得美国食品药品监督管理局上市前批准的新型高风险治疗设备制造商之间的市场竞争。
BMJ Surg Interv Health Technol. 2023 Feb 8;5(1):e000152. doi: 10.1136/bmjsit-2022-000152. eCollection 2023.
2
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.2010 年和 2011 年 FDA 上市前批准的高风险治疗性医疗器械全产品生命周期临床试验特点。
JAMA. 2015 Aug 11;314(6):604-12. doi: 10.1001/jama.2015.8761.
3
How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?骨科器械在首次获得美国食品药品监督管理局（FDA）上市前批准后会发生怎样的变化？
Clin Orthop Relat Res. 2016 Apr;474(4):1053-68. doi: 10.1007/s11999-015-4634-x. Epub 2015 Nov 19.
4
FDA Regulation and Approval of Medical Devices: 1976-2020.FDA 对医疗器械的监管与审批：1976-2020 年。
JAMA. 2021 Aug 3;326(5):420-432. doi: 10.1001/jama.2021.11171.
5
Improving the postmarket surveillance of total joint arthroplasty devices.改善全关节置换装置的上市后监测。
Open Rheumatol J. 2008;2:7-12. doi: 10.2174/1874312900802010007. Epub 2008 Feb 25.
6
Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.高风险心血管设备试验中的选择性报告：上市前批准摘要与已发表报告的横断面比较
BMJ. 2015 Jun 10;350:h2613. doi: 10.1136/bmj.h2613.
7
8
Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.2008-2017 年美国食品和药物管理局 510(k) 审批和上市前批准的医疗器械召回风险。
JAMA Netw Open. 2021 May 3;4(5):e217274. doi: 10.1001/jamanetworkopen.2021.7274.
9
What physicians should know about the regulation of Obstetric and Gynecologic Medical Devices.医生应该了解的关于妇产科医疗器械监管的知识。
J Reprod Med. 1983 Jan;28(1):3-11.
10
Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.III 类医疗器械的平均批准时间远高于 FDA 和 CMS 设定的法定截止日期。
Health Aff (Millwood). 2012 Oct;31(10):2304-13. doi: 10.1377/hlthaff.2010.1198.
引用本文的文献
1
FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program.美国食品药品监督管理局（FDA）在突破性器械计划下对治疗性器械的授权
JAMA Intern Med. 2025 Jun 30. doi: 10.1001/jamainternmed.2025.2235.
2
Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.美国食品药品监督管理局批准高风险医疗器械时的非同期对照使用
JAMA Netw Open. 2025 Apr 1;8(4):e256230. doi: 10.1001/jamanetworkopen.2025.6230.
本文引用的文献
1
Reimagining Pharmaceutical Market Exclusivities: Should the Duration of Guaranteed Monopoly Periods Be Value Based?重新构想药品市场专营权：有担保的垄断期期限是否应基于价值？
Value Health. 2021 Sep;24(9):1328-1334. doi: 10.1016/j.jval.2021.04.1277. Epub 2021 Aug 8.
2
Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.2011 年至 2019 年期间，通过 De Novo 途径获得美国食品和药物管理局批准的新型治疗设备的临床证据。
JAMA Intern Med. 2020 Dec 1;180(12):1701-1703. doi: 10.1001/jamainternmed.2020.3214.
3
Competitive Development in Pharmacologic Classes: Market Entry and the Timing of Development.药物类别中的竞争发展：市场准入和开发时机。
Clin Pharmacol Ther. 2016 Dec;100(6):754-760. doi: 10.1002/cpt.502. Epub 2016 Oct 14.
4
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.2010 年和 2011 年 FDA 上市前批准的高风险治疗性医疗器械全产品生命周期临床试验特点。
JAMA. 2015 Aug 11;314(6):604-12. doi: 10.1001/jama.2015.8761.
Zotero 插件