28
Science. doi: 10.1038/stemcells.2008.21. http://www.nature.com/stemcells/2008/0801/080117/
full/stemcells.2008.21.html. Accessed 7 May 2015
FDA (2010) Examples of combination product approvals. http://www.fda.gov/
CombinationProducts/AboutCombinationProducts/ucm101598.htm. Accessed 5 May 2015
FDA (2014a) Human cells, tissues, and cellular and tissue-based products (HCT/Ps) from adipose
tissue: regulatory considerations—draft guidance for industry. http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/
ucm427795.htm. Accessed 5 May 2015
FDA (2014b) Minimal manipulation of human cells, tissues, and cellular and tissue-based prod-
ucts—draft guidance for industry and food and drug administration staff. http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/
CellularandGeneTherapy/ucm427692.htm. Accessed 5 May 2015
Federal Food, Drug and Cosmetics Act 21 U.S.C. § 321(g)(1) (2006) SEC. 201. [21 U.S.C. 321]
CHAPTER II—DEFINITIONS
Feigal EG, Tsokas G, Viswanathan S et al (2014) International regulatory consideration on devel-
opment pathways for stem cell therapies. Stem Cells Portal. doi: 10.5966/sctm.2014-0122
Fishbach GD, Fishbach RL (2004) Stem cells: science, policy and ethics. J Clin Invest 114:
1364–1370
Foundation for the Accreditation of Cellular Therapy (FACT) (2015) http://factwebsite.org/
Standards/. Accessed 10 May 2015
Franklin S, Cornwell G (2005) Why patients do or don’t consent to donate their embryos to stem
cell research. Presentation at the HFEA research conference, London, UK. http://www.hfea.
gov.uk/Research/Researchnews/2005-12-01%20Research%20Conference%20-%20
Glenda%20Cornwell.pdf. Accessed 3 May 2015
General Health Act of 7 February 1984 (amended 2006; no English translation available);
Regulation on Scientifi c Research (1987; Spanish only); Regulation on the Sanitary Control of
Organs, Tissues and Human Cadavers (1985; Spanish only)
Genetic Integrity Act 2005 (Lag 2005:39), Swedish Code of Statutes No. 2006:351. http://www.
riksdagen.se/sv/Dokument-Lagar/Lagar/Svenskforfattningssamling/sfs_sfs-2006-351/.
Accessed 6 May 2015; Act on Measures for Purposes of Research or Treatment on the Use of
Fertilised Ova 1991 (Lag 1991:315); Swedish Code of Statutes No. 1991:115. http://www.
riksdagen.se/sv/Dokument-Lagar/Lagar/Svenskforfattningssamling/Lag-1991115-om-
atgarder-i-f_sfs-1991-115/?bet=1991:115. Accessed 6 May 2015
Guidelines for the Derivation and Utilisation of Human Embryonic Stem Cells (2001); Guidelines
on the derivation and distribution of human embryonic stem cells (20 May 2010, as revised).
http://www.lifescience.mext.go.jp/fi les/pdf/n743_00.pdf. Accessed 6 May 2015; Law concern-
ing regulation relating to human cloning techniques and similar techniques (2001). http://www.
mext.go.jp/a_menu/shinkou/seimei/eclone.pdf. Accessed 6 May 2015; Guidelines to the law
concerning regulation relating to human cloning techniques and similar techniques (2001).
http://www.mext.go.jp/a_menu/shinkou/seimei/2001/hai3/17_shishin.pdf. Accessed 12 Jan
2015; Guidelines for the handling of a specifi ed embryo (2001). http://www.mext.go.jp/a_
menu/shinkou/seimei/2001/hai3/31_shishin_e.pdf. Accessed 6 May 2015
Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research
(2006) New Zealand Ministry of Health. http://www.moh.govt.nz/notebook/nbbooks.nsf/0/7d
723ee803f89c67cc2576d5006cbbcc/$FILE/guidelines-stem-cell-use.pdf. Accessed 6 May
2015; Human Tissue Act 2008. http://www.legislation.govt.nz/act/public/2008/0028/latest/
DLM1152940.html. Accessed 6 May 2015; Human Assisted Reproductive Technology Act
- http://www.legislation.govt.nz/act/public/2004/0092/latest/whole.html. Accessed 6 May
2015
Health Care Law No. 277/1994 (no translated copy available); Slovak Penal Code (Law No.
141/1961) (no translated copy available); National regulations on ethics and research in the
Slovak Republic (2003). http://www.bioethics-singapore.org/uploadfi le/60517%20PMHSC%
20Research.pdf. Accessed 6 May 2015
W.M. Botes et al.