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. 2012 Aug 29;4(149):149fs31.
doi: 10.1126/scitranslmed.3004131.

FDA oversight of cell therapy clinical trials

Patrick Au  1 , Deborah A Hursh, Agnes Lim, Malcolm C Moos Jr, Steven S Oh, Bruce S Schneider, Celia M Witten
Affiliations

FDA oversight of cell therapy clinical trials

Patrick Au et al. Sci Transl Med. .

Abstract

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

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