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題名:美國細胞與基因治療品之法律規制模式評析:兼論United States v. Regenerative Scis., LLC案
書刊名:法律與生命科學
作者:楊佳陵呂庭瑄
出版日期:2017
卷期:6:1
頁次:頁21-32
主題關鍵詞:細胞療法基因療法再生醫療美國食品藥物管理立法歷程細胞與組織產品最小操作原則21 CFR 1271United States v. Regenerative Science
原始連結:連回原系統網址new window
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期刊論文
1.Wax, Paul M.(1995)。Elixirs, diluents, and the Passage of the 1938 Federal Food,Drug and Cosmetic Act。J ANN INTERN,122(6),456-461。  new window
2.Colgrove, James(2007)。Immunity for the People: The Challenge of Achieving High Vaccine Coverage in American History。Public Health Rep.,122(2),248-257。  new window
3.Nasr, Alexander、Lauterio, Thomas J.、Davis, Matthew W.(2011)。Unapproved drugs in the united states and the food and drug administration。Advances in Therapy,28(10),842-856。  new window
4.Sheridan, W. P.、Wolf, M.、Lusk, J.、Layton, J. E.、Souza, L.、Morstyn, G.、Dodds, A.、Maher, D.、Green, M. D.、Fox, R. M.(1989)。GRANULOCYTE COLONY-STIMULATING FACTOR AND NEUTROPHIL RECOVERY AFTER HIGH-DOSE CHEMOTHERAPY AND AUTOLOGOUS BONE MARROW TRANSPLANTATION。The Lancet,334(8668),891-895。  new window
5.Pivarnik, Greg(2014)。Cells as Drugs?: Regulating the Future of Medicine。AM. J.L. & MED.,40,298-321。  new window
6.Chirba, Mary Ann、Garfield, Stephanie M.(2011)。FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine?。J. HEALTH & BIOMEDICAL L.,7,233-270。  new window
7.Epstein, Richard A.(2013)。The FDA's Misguided Regulation of Stem Cell Procedures: How Administrative Overreach Blocks Medical Innovation。LEGAL POL'Y REP.,17。  new window
8.Caplan, Arnold I.、West, Michael D.(2014)。Progressive Approval: A Proposal for a New Regulatory Pathway for Regenerative Medicine。STEM CELLS TRANSLATIONAL MED.,3。  new window
9.Centeno, C. J.(2008)。Increased knee cartilage volume in degenerative joint disease using percutaneously implanted, autologous mesenchymal stem cells。Pain Physician,11。  new window
10.Hudson, Kathy L.、Collins, Francis S.(2017)。The 21st Century Cures Act - A View from the NIH。N Engl J Med,376,111-113。  new window
 
 
 
 
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