title: FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care.
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: E
authors.initials: E
authors.lastname: Hillebrenner
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: E
authors.initials: E
authors.lastname: Litwack
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: P
authors.initials: P
authors.lastname: Bradley
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Donigan
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: T
authors.initials: T
authors.lastname: Lowe
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Serrano
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Kelm
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: E
authors.initials: E
authors.lastname: Mansfield
authors.affiliation: Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: A
authors.initials: A
authors.lastname: Gutierrez
mesh_terms: D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration