Show simple item record

dc.creatorFink, Donald W., Jr.en
dc.date.accessioned2011-07-12T18:22:28Zen
dc.date.available2011-07-12T18:22:28Zen
dc.date.created2009-06-26en
dc.date.issued2009-06-26en
dc.identifier1095-9203en
dc.identifierhttp://www.sciencemag.org/archive/en
dc.identifier10.1126/science.1173712en
dc.identifier.bibliographicCitationScience 2009 June 26; 324(5935): 1662-1663en
dc.identifier.urihttp://hdl.handle.net/10822/514704en
dc.description.abstractCell self-renewal and the capacity to differentiate into multiple cell types (pluripotency) are biological attributes casting stem cells as attractive candidates for development of therapies targeting indications that involve functional restoration of damaged tissues. In the United States, clinical trials designed to demonstrate the safety and effectiveness of stem cell-based products are regulated by the U.S. Food and Drug Administration (FDA). To ensure that subjects enrolled in a clinical study involving stem cell-based products are not exposed to significant and unreasonable risk, the FDA reviews medical and scientific information that encompasses delineation of product-specific characteristics and preclinical testing to determine whether there is sufficient safety assurance to permit initiation of human clinical studies.en
dc.description.urihttp://dx.doi.org/10.1126/science.1173712en
dc.formatArticleen
dc.languageengen
dc.source326082en
dc.subjectCellsen
dc.subjectClinical Trialsen
dc.subjectFooden
dc.subjectRegulationen
dc.subjectRisken
dc.subjectStem Cellsen
dc.subject.classificationGenetics, Molecular Biology and Microbiologyen
dc.subject.classificationStem Cell Researchen
dc.titleFDA regulation of stem cell-based products.en
dc.provenanceDigital citation created by the Bioethics Research Library, Georgetown University, for the National Information Resource on Ethics and Human Genetics, a project funded by the United States National Human Genome Research Instituteen
dc.provenanceDigital citation migrated from OpenText Livelink Discovery Server database named GenETHX to DSpace collection GenETHX hosted by Georgetown Universityen


This item appears in the following Collection(s)

Show simple item record


Georgetown University Seal
©2009—2019 Bioethics Research Library
Box 571212 Washington DC 20057-1212
202.687.3885