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Scientific Publications by FDA Staff
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Sci Transl Med 2012 Aug 29;4(149):149fs31

FDA oversight of cell therapy clinical trials.

Au P, Hursh DA, Lim A, Moos MC Jr, Oh SS, Schneider BS, Witten CM

Abstract

The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

Category: Journal Article, Editorial
PubMed ID: #22932219 DOI: 10.1126/scitranslmed.3004131
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2012-08-31 Entry Last Modified: 2013-01-18
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