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題名:論醫療器材之民事責任:以美國規範為借鏡
書刊名:月旦醫事法報告
作者:江國慶
作者(外文):Chiang, Kuo-ching
出版日期:2018
卷期:15
頁次:頁41-53
主題關鍵詞:FDA豁免上市前批准程序專家中介醫療器材責任醫療器材管理FDA pre-emptionPremarket approvalLearned intermediary doctrineMedical device liabilityMedical device management
原始連結:連回原系統網址new window
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  • 被引用次數被引用次數:期刊(1) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:1
  • 共同引用共同引用:0
  • 點閱點閱:1
期刊論文
1.Geller, Kenneth S.、Gossett, David M.(2008)。Riegel v. Medtronic: A Victory for Patients and Device Manufactures in the US。RAJ Device,2008(Mar./Apr.)。  new window
其他
1.Levinson, Daniel R.(2013)。FDA's Clearance of Medical Devices Through the 510(k) Process。  new window
2.FDA。Regulatory Controls,https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm。  new window
3.FINDLAW。What is Product Liability?,http://injury.findlaw.com/product-liability/what-is-product-liability.html。  new window
4.State of Connecticut judicial branch。Product Liability: Failure to Warn,https://www.jud.ct.gov/ji/civil/Civil.pdf。  new window
5.Poser, Susan。Sample Prescription Drugs and the "Learned Intermediary": Liability without Preemption,http://works.bepress.com/susan_poser/1。  new window
 
 
 
 
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