The FDA De Novo medical device pathway, patents and anticompetition.

Jacob S Sherkow; Mateo Aboy

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The FDA De Novo medical device pathway, patents and anticompetition.

机译：FDA de Novo Medical Device Device路径，专利和防抱。

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来源
《Nature biotechnology》 |2020年第9期|共2页
作者
Jacob S Sherkow; Mateo Aboy;
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作者单位

College of Law University of Illinois at Urbana-Champaign;

Centre for Law Medicine and Life Sciences University of Cambridge;

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原文格式 PDF
正文语种 eng
中图分类普通生物学;
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入库时间 2022-08-20 18:29:45

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1. Pathway mining-based integration of critical enzyme parts for de novo biosynthesis of steviolglycosides sweetener in Escherichia coil [J] . Jianfeng Wang, Shiyuan Li, Zhiqiang Xiong, 细胞研究（英文版） . 2016,第002期
2. A de novo originated gene depresses budding yeast mating pathway and is repressed by the protein encoded by its antisense strand [J] . Dan Li, Yang Dong, Yu Jiang, 细胞研究：英文版 . 2010,第004期
3. A de novo originated gene depresses budding yeast mating pathway and is repressed by the protein encoded by its antisense strand [J] . Dan Li, Yang Dong, Yu Jiang, 细胞研究（英文版） . 2010,第004期
4. Overlap graphs and de Bruijn graphs: data structures for de novo genome assembly in the big data era [J] . Raffaella Rizzi, Stefano Beretta, Murray Patterson, 定量生物学（英文版） . 2019,第004期
5. MEDICAL DEVICE ASSEMBLY: FDA to Modernize 510(k)Clearance Pathway [J] . JOHN SPROVIERI Assembly . 2019,第4期

机译：医疗器械组件：FDA至现代化510（k）间隙途径
6. FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results [J] . null Laboratory industry report . 2019,第2期

机译：FDA手表：机构最终确定新的医疗器械营销途径和okays直接实验室报告PGX测试结果
7. The FDA and the Vaginal Mesh Controversy-Further Impetus to Change the 510(k) Pathway for Medical Device Approval [J] . Jacoby Vanessa L., Subak Leslee, Waetjen L. Elaine JAMA internal medicine . 2016,第2期

机译：FDA和阴道网的争议-进一步推动改变510（k）医疗器械批准途径
8. Testing leading to a 'de novo' (i.e., no predicate) FDA cleared antimicrobial wound dressing [C] . Chris Batich, Greg Schultz, William Toreki, Society for Biomaterials annual meeting and exposition . 2015

机译：导致“从头”（即没有谓词）的测试FDA清除了抗菌伤口敷料
9. Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products =Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos [D] . Rojas, KM. 2020

机译：项目管理实践和FDA人类因素成功的关键因素医疗设备和组合产品的验证= FDA人类因素验证设备的项目管理和因素管理实践
10. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration [O] . Joseph P Drozda Jr, James Roach, Thomas Forsyth, 2018

机译：构建医疗设备评估系统的信息和信息技术基础：FDA唯一设备标识符演示中的报告
11. The FDA De Novo medical device pathway, patents and anticompetition [O] . Jacob S. Sherkow, Mateo Aboy 2020

机译：FDA de Novo医疗器械途径，专利和防抱
12. Expedited Access for Pre-Market Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions: Guidance for Industry and Food and Drug Administration Staff. [R] . 2014

机译：快速进入上市前批准和De Novo医疗器械用于未满足医疗需求的生命威胁或不可逆转的衰弱疾病或条件：工业和食品药品管理局工作人员指南。

The FDA De Novo medical device pathway, patents and anticompetition.

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