FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care

J Clin Pharmacol. 2015 Jul;55(7):728-30. doi: 10.1002/jcph.521.

Authors

E Hillebrenner¹, E Litwack¹, P Bradley¹, K Donigan¹, T Lowe¹, K Serrano¹, K Kelm¹, E Mansfield¹, A Gutierrez¹

Affiliation

¹ Office of In Vitro Diagnostics and Radiological Health, Center for Diagnostics and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.

PMID: 26053648
DOI: 10.1002/jcph.521

No abstract available

MeSH terms

Clinical Laboratory Services / legislation & jurisprudence*
Clinical Laboratory Techniques / standards*
Humans
Pharmacogenetics / methods*
United States
United States Food and Drug Administration