title: An outsider's viewpoint: the FDA should regulate clinical pharmacogenetic/genomic tests, but....
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA. okane.dennis@mayo.edu
authors.forename: D
authors.initials: D
authors.lastname: O'Kane
mesh_terms: D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D023281:Genomics / Q000331:legislation & jurisprudence*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence*; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*