Document Detail

The impact of regulatory policy on the development of somatic cell therapies in the United States.
MedLine Citation:
PMID:  12180844     Owner:  NLM     Status:  MEDLINE    
Cellular therapies offer new promise for the treatment of a variety of diseases. In order to protect patients and donors, the Food and Drug Administration in the USA has been developing specific regulations. These have undergone several iterations, however, a broad-based strategy has recently emerged. These proposals are reviewed and their impact on academic institutions is assessed.
Adrian P Gee
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Transplant immunology     Volume:  9     ISSN:  0966-3274     ISO Abbreviation:  Transpl. Immunol.     Publication Date:  2002 May 
Date Detail:
Created Date:  2002-08-15     Completed Date:  2003-03-18     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9309923     Medline TA:  Transpl Immunol     Country:  England    
Other Details:
Languages:  eng     Pagination:  295-300     Citation Subset:  IM    
Center For Cell and Gene Therapy, Baylor College of Medicine, Feigin Center, Houston, TX 77030, USA.
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MeSH Terms
Cell Transplantation / economics,  legislation & jurisprudence*,  standards
Facility Regulation and Control / legislation & jurisprudence
Gene Therapy / economics,  legislation & jurisprudence*,  standards
Health Care Costs
Health Policy / legislation & jurisprudence
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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