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FDA regulation of stem-cell-based therapies

Article Abstract:

The Food and Drug Administration (FDA) has provided an appropriate regulatory structure for stem-cell-based products, which might be developed to replace or repair damaged tissue. The existing regulations regarding cell and tissue products that the FDA is likely to apply to the preclinical development and testing of various types of stem-cell-based therapies are outlined.

Author: Kessler, David A., Halme, Dina Gould
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2006
Government domestic functions, Stem cell transplantation, United States. Food and Drug Administration, Health policy

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Cloning and stem cells -- handicapping the political and scientific debates

Article Abstract:

A scientist at the Whitehead Institute for Biomedical Research hopes Congress will pass legislation permitting the cloning of embryonic tissue for the production of stem cells even if it prohibits reproductive cloning. Embryonic tissue is the only source of stem cells that can mature into any type of tissue. For this reason, they could be used to treat many diseases.

Author: Daley, George Q.
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2003
Cloning

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The stem-cell market - Patents and the pursuit of scientific progress

Article Abstract:

Wisconsin Alumni Research Foundation's agreements with academic researchers are discussed which included critical limitations on the purposes for which stem-cell lines could be used and on the sharing of cells with other researchers.

Author: Murray, Fiona
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2007
Science & research, Research, Wisconsin Alumni Research Foundation, Stem cell research

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Subjects list: United States, Laws, regulations and rules, Government regulation, Stem cells
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