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1
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33845196527
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Combination Products Regulation. Title 21 US Code of Federal Regulations, Part 3.2(e).
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2
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33845198161
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Donor Eligibility Regulation. Title 21 US Code of Federal Regulations, Part 1271.45.
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3
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33845210645
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Exemptions and Alternatives Regulation. Title 21 US Code of Federal Regulations, Part 1271.155.
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4
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33845212015
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Federal Food, Drug and Cosmetic Act, Title 21, USC §321(g), §201(g).
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5
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33845201489
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General Biological Product Standards Regulation. Title 21 US Code of Federal Regulations, Part 610.
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6
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33845197254
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Genzyme Biosurgery
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Genzyme Biosurgery. Epicel Package Insert (2002). http://www.genzymebiosurgery.com/pdfs/epicel_package_insert.pdf
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(2002)
Epicel Package Insert
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7
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33845222765
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Good Manufacturing Practices Regulation. Title 21 US Code of Federal Regulations, Parts 210 and 211.
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11
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33845185830
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Investigational New Drug Applications. Title 21, US Code of Federal Regulations, Part 312.
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12
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0027517610
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Regulation of somatic cell therapy and gene therapy by the Food and Drug Administration
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Kessler D.A., Siegel J.P., Noguchi P.D., et al. Regulation of somatic cell therapy and gene therapy by the Food and Drug Administration. N. Engl. J. Med. 329 (1993) 1169-1173
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Kessler, D.A.1
Siegel, J.P.2
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13
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33845218506
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Title 21 US Code of Federal Regulations. Medical Devices Regulation. Title 21 US code of Federal Regulations, Part 814.
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14
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33845198390
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Public Health Service Act. Title 42, USC §262, §351.
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15
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0001040720
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Application of current statutory authorities to human somatic cell therapy products and gene therapy products: Notice
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US Food and Drug Administration 58FR
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US Food and Drug Administration. Application of current statutory authorities to human somatic cell therapy products and gene therapy products: Notice. Federal Register (1993) 53248 58FR
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Federal Register
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18
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33845205334
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Biologics Response Modifiers Advisory Committee
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US Food and Drug Administration. FDA briefing document. 2000 July 13-14 Available at
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US Food and Drug Administration. Biologics Response Modifiers Advisory Committee. FDA briefing document. 2000 July 13-14. Human Stem Cells as Cellular Replacement Therapies for Neurological Disorders (2000). http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3629b1.htm Available at
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Human Stem Cells as Cellular Replacement Therapies for Neurological Disorders
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19
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33845193706
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US Food and Drug Administration. Letter from B. Schwetz, Office of the Commissioner, to Senator Edward Kennedy, 8 September 2001. Available at
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US Food and Drug Administration. Letter from B. Schwetz, Office of the Commissioner, to Senator Edward Kennedy, 8 September 2001. Available at (2001). http://www.fda.gov/oc/stemcells/kennedyltr.html
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20
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33845224588
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Biologics Response Modifiers Advisory Committee
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US Food and Drug Administration. 2003 Oct. 09-10. Available at
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US Food and Drug Administration. Biologics Response Modifiers Advisory Committee. 2003 Oct. 09-10. Available at. Allogeneic pancreatic islets for the treatment of type 1 diabetes, FDA briefing document (2003). www.fda.gov/ohrms/dockets/ac/03/briefing/3986b1.htm
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(2003)
Allogeneic pancreatic islets for the treatment of type 1 diabetes, FDA briefing document
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25
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33845193462
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Biologics Response Modifiers Advisory Committee
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US Food and Drug Administration
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US Food and Drug Administration. Biologics Response Modifiers Advisory Committee. Cellular products for the treatment of cardiac disease, FDA briefing document (2004). 2004 Mar 18. Available at www.fda.gov/ohrms/dockets/ac/04/briefing/4018b1.htm
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Cellular products for the treatment of cardiac disease, FDA briefing document
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28
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33845194822
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Cellular, Tissue and Gene Therapies Advisory Committee
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US Food and Drug Administration
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US Food and Drug Administration. Cellular, Tissue and Gene Therapies Advisory Committee. Potency Measurements for Cellular and Gene Therapy Products. FDA briefing document (2006). 2006 Feb. 09-10. Available at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4205B1-index.htm
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Potency Measurements for Cellular and Gene Therapy Products. FDA briefing document
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29
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33845219410
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Cellular, Tissue and Gene Therapies Advisory Committee
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US Food and Drug Administration
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US Food and Drug Administration. Cellular, Tissue and Gene Therapies Advisory Committee. Cellular Products for Joint Surface Repair. FDA briefing document (2005). 2005 Mar 03. Available at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4093b2.htm
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Cellular Products for Joint Surface Repair. FDA briefing document
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31
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Biosafety considerations for cell-based therapies
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Navigating FDA regulations for human cells and tissues
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Weber D.J. Navigating FDA regulations for human cells and tissues. BioProcessing Int. 2 8 (2004) 22-26
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