title: FDA comments on phase I clinical trials without vector biodistribution data.
authors.forename: S
authors.initials: S
authors.lastname: Epstein
authors.forename: S
authors.initials: S
authors.lastname: Bauer
authors.forename: A
authors.initials: A
authors.lastname: Miller
authors.forename: A
authors.initials: A
authors.lastname: Pilaro
authors.forename: P
authors.initials: P
authors.lastname: Noguchi
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000009:adverse effects*; D005822:Genetic Vectors; D018095:Germ-Line Mutation; D006801:Humans; D016254:Mutagenesis, Insertional; D014018:Tissue Distribution; D014481:United States; D014486:United States Food and Drug Administration