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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.

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.

DOI:10.1136/bmjsit-2022-000152
PMID:36793371
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9923248/
Abstract
摘要