-
1
-
-
70349588614
-
-
Geron (2009). Geron Receives FDA Clearance to begin world's first human clinical trial of embryonic stem cell-based therapy. News Release January 23, 2009. Accessed February 2, 2009, at
-
Geron (2009). Geron Receives FDA Clearance to begin world's first human clinical trial of embryonic stem cell-based therapy. News Release January 23, 2009. Accessed February 2, 2009, at http://www.geron.com/media/pressview.aspx?id=863.
-
-
-
-
2
-
-
70349587312
-
-
Geron (2009). FDA Places Geron's GRNOPC1 IND on clinical hold. News Release May 14, 2008. Accessed February 2, 2009, at
-
Geron (2009). FDA Places Geron's GRNOPC1 IND on clinical hold. News Release May 14, 2008. Accessed February 2, 2009, at http://www.geron.com/media/pressview.aspx?id=840.
-
-
-
-
3
-
-
70349587309
-
-
Pollack, A. (2009). F.D.A. approves a stem cell trial. New York Times January 23, 2009. Accessed February 2, 2009, at
-
Pollack, A. (2009). F.D.A. approves a stem cell trial. New York Times January 23, 2009. Accessed February 2, 2009, at http://www.nytimes.com/2009/01/23/business/23stem.html?scp=1&sq=pollack%20geron&st=cse.
-
-
-
-
4
-
-
70349594459
-
-
International Society for Stem Cell Research (2008). Guidelines for the clinical translation of stem cells. December 3. Accessed February 2, 2009, at
-
International Society for Stem Cell Research (2008). Guidelines for the clinical translation of stem cells. December 3. Accessed February 2, 2009, at http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf.
-
-
-
-
5
-
-
56549103448
-
Stem cell clinics online: The direct-to-consumer portrayal of stem cell medicine
-
Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., Caulfield, T. (2008). Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell, 3, 591-594.
-
(2008)
Cell Stem Cell
, vol.3
, pp. 591-594
-
-
Lau, D.1
Ogbogu, U.2
Taylor, B.3
Stafinski, T.4
Menon, D.5
Caulfield, T.6
-
6
-
-
44949187534
-
FDA scrutinizes human stem cell therapies
-
Fox, J. L. (2008). FDA scrutinizes human stem cell therapies. Nature Biotechnology, 26, 598-599.
-
(2008)
Nature Biotechnology
, vol.26
, pp. 598-599
-
-
Fox, J.L.1
-
7
-
-
70349601041
-
-
Scott, C. T. (2008). Weighing risks and rewards en route to the clinic. Nature Reports Stem Cells, December 18, 2008. doi:10.1038/stemcells.2008.158
-
Scott, C. T. (2008). Weighing risks and rewards en route to the clinic. Nature Reports Stem Cells, December 18, 2008. doi:10.1038/stemcells.2008.158.
-
-
-
-
8
-
-
70349596206
-
-
EC. Regulation (EC) No 1394 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, [2007] O.J. L 324/121
-
EC. Regulation (EC) No 1394 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, [2007] O.J. L 324/121.
-
-
-
-
9
-
-
70349585967
-
-
United States Food and Drug Administration (1998). Guidance for human somatic cell therapy and gene therapy. FDA Center for Biologics Evaluation and Research
-
United States Food and Drug Administration (1998). Guidance for human somatic cell therapy and gene therapy. FDA Center for Biologics Evaluation and Research.
-
-
-
-
10
-
-
70349594457
-
-
World Medical Association (2008). Declaration of Helsinki: ethical principles for medical research involving human subjects. Amended October 2008. Accessed February 2, 2009, at
-
World Medical Association (2008). Declaration of Helsinki: ethical principles for medical research involving human subjects. Amended October 2008. Accessed February 2, 2009, at http://www.wma.net/e/policy/b3.htm.
-
-
-
-
11
-
-
70349585552
-
-
United States. Food and Drugs, Regulation, 21 C.F.R., Part 312, § 312.34
-
United States. Food and Drugs, Regulation, 21 C.F.R., Part 312, § 312.34.
-
-
-
-
12
-
-
70349593091
-
-
Canada. Food and Drug Regulations, C.R.C., c. 870, s. C.08.010-011
-
Canada. Food and Drug Regulations, C.R.C., c. 870, s. C.08.010-011.
-
-
-
-
13
-
-
70349594458
-
-
EC. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, [2001] O.J. L 311/67
-
EC. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, [2001] O.J. L 311/67.
-
-
-
-
14
-
-
70349602374
-
-
Health Canada (2008). Guidance document for industry and practitioners: special access programme for drugs. Health Products and Food Branch. Accessed February 2, 2009, at
-
Health Canada (2008). Guidance document for industry and practitioners: special access programme for drugs. Health Products and Food Branch. Accessed February 2, 2009, at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/acces/sapg3_pasg3-eng.pdf.
-
-
-
-
15
-
-
34250174578
-
Is it sound public policy to let the terminally ill access experimental medical innovations?
-
Caplan, A. (2007). Is it sound public policy to let the terminally ill access experimental medical innovations? Am J Bioethics, 7(6), 1-3.
-
(2007)
Am J Bioethics
, vol.7
, Issue.6
, pp. 1-3
-
-
Caplan, A.1
-
16
-
-
70349588613
-
-
United Kingdom Medicines and Healthcare products Regulatory Agency (2008). Concept paper on the review of the regulation of unlicensed medicines. Accessed February 2, 2009, at
-
United Kingdom Medicines and Healthcare products Regulatory Agency (2008). Concept paper on the review of the regulation of unlicensed medicines. Accessed February 2, 2009, at http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/Othermedicinesconsultations/CON014086.
-
-
-
-
17
-
-
70349590420
-
-
EC. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, [2004] O.J. L 102/48
-
EC. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, [2004] O.J. L 102/48.
-
-
-
-
18
-
-
70349606760
-
-
Canada. Safety of Human Cells, Tissues and Organs for Transplantation Regulations, S.O.R./2007-118
-
Canada. Safety of Human Cells, Tissues and Organs for Transplantation Regulations, S.O.R./2007-118.
-
-
-
-
19
-
-
70349601040
-
-
United States. Human Cells, Tissues, and Cellular and Tissue-Based Products Regulations, 21 C.F.R., Part 1271
-
United States. Human Cells, Tissues, and Cellular and Tissue-Based Products Regulations, 21 C.F.R., Part 1271.
-
-
-
-
20
-
-
70349601038
-
The rationale for a registry of clinical trials involving human stem cell therapies
-
Isasi, R., Nguyen, T. M. (2008). The rationale for a registry of clinical trials involving human stem cell therapies. Health Law Rev, 16(2), 56-68.
-
(2008)
Health Law Rev
, vol.16
, Issue.2
, pp. 56-68
-
-
Isasi, R.1
Nguyen, T.M.2
-
21
-
-
70349598362
-
-
Experts Committee for Human Research Participant Protection in Canada (2008). Moving ahead: Final report. Accessed February 2, 2009, at
-
Experts Committee for Human Research Participant Protection in Canada (2008). Moving ahead: Final report. Accessed February 2, 2009, at http://www.hrppc-pphrc.ca/english/movingaheadfinalreport2008.pdf.
-
-
-
-
23
-
-
70349603744
-
-
Canadian Institutes of Health Research (2007). Updated guidelines for human pluripotent stem cell research, June 29, 2007. Accessed February 2, 2009, at
-
Canadian Institutes of Health Research (2007). Updated guidelines for human pluripotent stem cell research, June 29, 2007. Accessed February 2, 2009, at http://www.cihr-irsc.gc.ca/e/34460.html.
-
-
-
-
24
-
-
70349596202
-
Raising the bar: Ethics review, governance, and accountability in community-based human health research
-
Davies, M. (2008). Raising the bar: ethics review, governance, and accountability in community-based human health research. Saskatchewan Law Review, 71, 91-116.
-
(2008)
Saskatchewan Law Review
, vol.71
, pp. 91-116
-
-
Davies, M.1
-
25
-
-
70349602372
-
-
Therapeutic Goods Administration (Australia) (2008). Summary of the human cell and tissue therapies framework. Accessed February 2, 2009, at
-
Therapeutic Goods Administration (Australia) (2008). Summary of the human cell and tissue therapies framework. Accessed February 2, 2009, at http://www.tga.gov.au/bt/hctsum.htm.
-
-
-
-
26
-
-
34347252630
-
Health Canada's progressive licensing framework
-
Yeates, N., Lee, D. K., Maher, M. (2007). Health Canada's progressive licensing framework. CMAJ, 176, 1845-1847.
-
(2007)
CMAJ
, vol.176
, pp. 1845-1847
-
-
Yeates, N.1
Lee, D.K.2
Maher, M.3
-
27
-
-
70349596203
-
-
Parliament of Canada (2008). Bill C-51: an act to amend the food and drugs act and to make consequential amendments to other acts. 39th Parliament, 2nd Session
-
Parliament of Canada (2008). Bill C-51: an act to amend the food and drugs act and to make consequential amendments to other acts. 39th Parliament, 2nd Session.
-
-
-
-
28
-
-
34347249149
-
Progressive licensing needs progressive open debate
-
Hebert, P. C. (2007). Progressive licensing needs progressive open debate. CMAJ, 176, 1801.
-
(2007)
CMAJ
, vol.176
, pp. 1801
-
-
Hebert, P.C.1
-
29
-
-
70349585966
-
-
European Medicines Agency (2008). Guideline on safety and efficacy follow-up-risk management on advanced therapy medicinal products. London
-
European Medicines Agency (2008). Guideline on safety and efficacy follow-up-risk management on advanced therapy medicinal products. London.
-
-
-
-
30
-
-
70349591738
-
Selling the stem cell dream
-
Enserink, M. (2005). Selling the stem cell dream. Science, 131, 160-163.
-
(2005)
Science
, vol.131
, pp. 160-163
-
-
Enserink, M.1
-
31
-
-
70349587307
-
-
Pray, L., Robinson, S. (2007). Challenges for the FDA: the future of drug safety, Workshop summary. National Academies
-
Pray, L., Robinson, S. (2007). Challenges for the FDA: the future of drug safety, Workshop summary. National Academies.
-
-
-
-
32
-
-
55549123091
-
Globalisation, harmonisation and the regulation of therapeutic products: The Australia New Zealand Therapeutic Products Authority Project in global context
-
von Tigerstrom, B. (2007). Globalisation, harmonisation and the regulation of therapeutic products: the Australia New Zealand Therapeutic Products Authority Project in global context. Canterbury Law Rev, 13, 287-313.
-
(2007)
Canterbury Law Rev
, vol.13
, pp. 287-313
-
-
von Tigerstrom, B.1
|