title: A Food and Drug Administration primer.
authors.affiliation: Harvard Medical School, Beth Israel Deaconess Medical Center, 110 Francis Street 4B, Boston, MA 02115, USA. lsimon@bidmc.harvard.edu
authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
mesh_terms: D017277:Drug Approval / Q000379:methods* / Q000458:organization & administration*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*