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Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes

机译：现实世界的证据应用于关于糖尿病新制药和医疗器械产品的监管决定

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David C. Klonoff; Alberto Gutierrez; Alexander Fleming; David Kerr;
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1. International Co-operation Heads Regulatory Plans in Japan Faraz Kermani talks to top-level officials from Japan's Pharmaceuticals and Medical Devices Agency about the country's regulatory strategies. [J] . Faraz Kermani The regulatory affairs journal: Pharma . 2009,第7期

机译：日本国际合作负责人监管计划Faraz Kermani与日本制药和医疗器械局的高级官员就该国的监管策略进行了交谈。
2. Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products : Current Directions in Biomedical Engineering [J] . Magdalena Kedwani, J?rg Schr?ttner, Christian Baumgartner Current Directions in Biomedical Engineering . 2019,第1期

机译：为开发医疗产品制造商的有效注册程序而对全球医疗设备和体外诊断的法规要求进行分析：生物医学工程的当前方向
3. Advances in the Use of Real-World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology [J] . Fleurence Rachael L., Shuren Jeffrey Clinical Pharmacology and Therapeutics . 2019,第1期

机译：使用现实世界证据的使用进展：卫生技术国家评估系统的更新
4. Letters to Medical Devices: A Case Study on the Medical Device User Requirements of Female Adolescents and Young Adults with Type 1 Diabetes [C] . Gillian M. McCarthy, Edgar R. Rodriguez Ramirez, Brian J. Robinson International conference on persuasive technology . 2017

机译：给医疗器械的信函：以女性青少年和1型糖尿病成年人的医疗器械使用者需求为例
5. Effective Strategic Decision-Making Strategies for Plant Managers in Pharmaceutical and Medical Device Manufacturing in Modern Day Puerto Rico: A Qualitative Case Study [D] . ?Jerez, Cherisa 2020

机译：有效的战略决策策略工厂管理人员在制药和医疗设备在现代波多黎各制造业：定性案例研究
6. Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes [O] . David C. Klonoff, Alberto Gutierrez, Alexander Fleming, 2019

机译：有关糖尿病的新药品和医疗器械产品的监管决策应使用真实证据
7. Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products [O] . Magdalena Kedwani, Jörg Schröttner, Christian Baumgartner 2019

机译：在全球医疗设备和体外诊断的监管要求分析，为医疗产品制造商进行高效注册程序的开发

Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes

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