FDA oversight of cell therapy clinical trials.

Au, Patrick; Hursh, Deborah A; Lim, Agnes; Moos, Malcolm C; Oh, Steven S; Schneider, Bruce S; Witten, Celia M · Sci Transl Med · 2012

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Abstract

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

Medical subject headings