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題名:藥品OFF-LABEL USE之管制--以美國與臺灣為例(上)
書刊名:法學新論
作者:廖建瑜
作者(外文):Liao, Chien-yu
出版日期:2011
卷期:31
頁次:頁37-64
主題關鍵詞:告知後同意仿單外使用注意義務不正請求禁止法仿單外使用行銷OFF-LABEL USEStandard of careFalse claims actInformed consentOff-label promotion
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(3) 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:3
  • 共同引用共同引用:1
  • 點閱點閱:45
期刊論文
1.Richard, C. Ausness(2008)。There’s Danger Here, Cherie!: Liability for the Promotion and Marketing of Drug and Medical Devices for Off-Label Use。BROOK. L. REV.,73,1253。  new window
2.James, O.(2003)。Off-Label or Out of Bounds? Prescriber and Marketer Liability for Unapproved Use of FDA-Approved Drugs。Annals Health L.,12,295。  new window
3.David, C. Radley(2006)。Off-Label Prescribing Among Office- Based Physicians。Arch. Intern. Med.,166,1021-1023。  new window
4.Randall, S. Stafford(2008)。Perspective: Regulating Off-Label Drug Use Rethinking the Role of the FDA。N. ENGL J MED.,358,1427。  new window
5.Margaret, Z. Johns(2007)。Informed Consent: Requiring Doctors to Disclose Off-Label Use Prescription and Conflicts of Interest。HASTINGS L.J.,58,967。  new window
6.Edward, P. Lansdale(2006)。Used As Directed? How Prosecutors Are Expanding the False Claims Act to Police Pharmaceutical Off-Label Marketing。NEW ENG. L. Rev.,41,159-161。  new window
7.John, E. Osborn(2010)。Can I, Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information。YALE J. HEALTKPol’y, L, & ETHICS,10,299+309-310+324-325。  new window
8.Richard, C. Ausness(2002)。Will More Aggressive Marketing Practices Lead to Greater Tort Liability for Prescription Drug Manufacturers。Wake FOREST L. Rev,37,97+106-107。  new window
9.陳汝吟(20041200)。論網路DTC廣告之法律規範--以藥物DTC廣告對隱私權保障及產品責任影響為例。玄奘法律學報,2,281-331。new window  延伸查詢new window
10.Daniel, W. Whitney(2010)。Guide to Preemption of State-Law Claims Against Class III Pma Medical Devices。FOOD & DRUG L.J.,65,113。  new window
11.Stephanie, Greene(2005)。False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products。PENN. St. L’Rev.,110,41+53-54。  new window
12.John, Moore V.(1991)。The Regents of the University of California。Cal. Rptr.,271,146。  new window
13.Cynthia, A. Moyer(2005)。Off-Label Use and the Medical Negligence Standard Under Minnesota Law。Wm. Mitchell L. Rev.,31,927+930-931。  new window
14.Bird, James R.(1977)。Package Inserts for Prescription Drugs as Evidence in Medical Malpractice Suits。The University of Chicago Law Review,44(2),398-456。  new window
15.Mark, Herrmann、Pearson, Bownas(2009)。Keeping the Label Out of the Case。Nw. U. L. Rev. Colloquy,103,477。  new window
16.Schwartz, Teresa Moran(1991)。Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule。Food Drug COSM. L.J.,46,829-830。  new window
學位論文
1.陳俞漶(1999)。臺北地區醫學中心醫師對藥品核准標示外使用的認知、態度與使用概況(碩士論文)。臺灣大學。  延伸查詢new window
2.林恩萱(2005)。Carbamazepine藥品核准標示外使用 (Off-LabelUse) 之研究(碩士論文)。國立陽明大學。  延伸查詢new window
其他
1.FDA(1998)。Information Sheets Guidance for Institutional Review Boards and Clinical Investigators,http://www.fda.gov/oc/ohrt/irbs/toc4.html, 2011/11/05。  new window
2.汪紹銘(2010)。藥品之仿單外使用(OFF-LABEL USE)之法律問題,http://www.rootlaw.com,tw/blog/wanglawyer2/?p=441, 2010/01/03。  延伸查詢new window
3.財團法人藥害救濟基金會(1999)。1999年至2010年7月藥害救濟申請暨審議案件統計資料,http://www.tdrf.org.tw/ch/05knows/kno_07_main.asp?bullid=3967, 2010/08/31。  延伸查詢new window
4.(2010)。醫療援助計畫是一個聯邦和州設的醫療保險補助方案,提供全面及廣泛的醫療服務,包括支付處方藥費用,給低收入和資源有限的人士,http://www.nyc.gov/html/caregiver/zh/paying2.html, 2010/01/02。  延伸查詢new window
 
 
 
 
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