title: The FDA regulatory process for drug and genetic diagnostic test approvals.
authors.affiliation: Department of Medicine, University of Colorado, Denver, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Bristow
authors.forename: William R
authors.initials: WR
authors.lastname: Hiatt
mesh_terms: D057069:Diagnostic Test Approval; D017277:Drug Approval; D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration