Document Detail


FDA oversight of cell therapy clinical trials.
MedLine Citation:
PMID:  22932219     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.
Authors:
Patrick Au; Deborah A Hursh; Agnes Lim; Malcolm C Moos; Steven S Oh; Bruce S Schneider; Celia M Witten
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Science translational medicine     Volume:  4     ISSN:  1946-6242     ISO Abbreviation:  Sci Transl Med     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-30     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101505086     Medline TA:  Sci Transl Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  149fs31     Citation Subset:  IM    
Affiliation:
Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.
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