FDA regulation of stem cell-based products.
Fink, Donald W., Jr.
Science 2009 June 26; 324(5935): 1662-1663
Cell 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.
Permanent LinkFind Full Text at Georgetown University Library
Full Text from Publisher
Showing items related by title, author, creator and subject.
Chester, Ronald; Sackstein, Robert (2010)The breakneck speed of scientific developments in embryonic stem (ES) cell technologies is, commensurately, ushering forth new bioethical debate(s) regarding these cells. A framework of bioethical principles is presented ...
Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges. Hyun, Insoo (2010-06)This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not ...