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Balancing Pre-Market and Post-Market Data Collection for Devices Subject to Pre-Market Approval: Guidance for Industry and Food and Drug Administration Staff.

机译：为获得上市前批准的设备平衡上市前和上市后数据收集：工业和食品和药品管理人员指南。

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年度 2015
页码 1-19
总页数 19
原文格式 PDF
正文语种 eng
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关键词
Economic conditions; Market analysis; Housing market; Metropolitan areas; Guidelines; Statistical data; Employment; Population; Households; Housing market analysis; Market conditions; Housing inventory; Pre-Katrina; Post-Katrina; Pre-Rita; Post-Rita;

机译：经济状况;市场分析;住房市场;大都市区;准则;统计数据;就业;人口;住户;住房市场分析;市场条件;住房清单;卡特里娜飓风前;卡特里娜飓风后;前丽塔;后丽塔;

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1. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: A case study of breast cancer screening and diagnostic devices [J] . VreugdenburgT.D., WillisC.D., MundyL., Internal medicine journal . 2013,第1期

机译：澳大利亚医疗器械的上市前批准和上市后直接面向消费者的广告：以乳腺癌筛查和诊断设备为例
2. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: A case study of breast cancer screening and diagnostic devices [J] . VreugdenburgT.D., WillisC.D., MundyL., Internal medicine journal . 2013,第1期

机译：澳大利亚医疗器械的上市前批准和上市后直接面向消费者的广告：以乳腺癌筛查和诊断设备为例
3. Acceptance of overseas clinical trial data of medical devices for pre-market registration:general principles and considerations of the National Medical Products Administration [J] . Shan Ju, Ying-Hui Liu, Yi-Dan Zhang, 中华医学杂志（英文版） . 2021,第018期

机译：验收海外临床试验数据的医疗设备预订注册：国家医疗产品管理的一般原则和考虑因素
4. Medical Device Approval Process in China since the Introduction of the China Food and Drug Administration [C] . Tobias Lueddemann, Diqing Chang, Sadik Sahin, IEEE Symposium on Product Compliance Engineering . 2016

机译：中国食品和药物管理局引进以来中国医疗器械批准过程
5. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
6. Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals [O] . Austin Lammers, Ruibin Wang, Jeremy Cetnar, 2017

机译：从美国食品药品监督管理局批准到癌症药物数据发布的时间：首次批准与后续批准的比较
7. Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals [O] . Austin Lammers, Ruibin Wang, Jeremy Cetnar, 2017

机译：从美国食品和药物管理局批准对癌症药物的数据发表的时间：比较第一和后续批准
8. 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。

Balancing Pre-Market and Post-Market Data Collection for Devices Subject to Pre-Market Approval: Guidance for Industry and Food and Drug Administration Staff.

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