title: FDA oversight of cell therapy clinical trials.
abstract: The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.
authors.affiliation: Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA. pakwai.au@fda.hhs.gov
authors.forename: Patrick
authors.initials: P
authors.lastname: Au
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Hursh
authors.forename: Agnes
authors.initials: A
authors.lastname: Lim
authors.forename: Malcolm C
authors.initials: MC
authors.lastname: Moos
authors.forename: Steven S
authors.initials: SS
authors.lastname: Oh
authors.forename: Bruce S
authors.initials: BS
authors.lastname: Schneider
authors.forename: Celia M
authors.initials: CM
authors.lastname: Witten
mesh_terms: D001691:Biological Therapy / Q000009:adverse effects / Q000592:standards; D017690:Cell Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D012107:Research Design / Q000331:legislation & jurisprudence* / Q000592:standards; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000592:standards