FDA's draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing

J Clin Pharmacol. 2015 Jul;55(7):725-7. doi: 10.1002/jcph.492.

Authors

Kenneth D Levy¹, Victoria M Pratt², Todd C Skaar¹, Gail H Vance³, David A Flockhart^{1

4}

Affiliations

¹ Department of Medicine, Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN, USA.
² Pharmacogenetics Laboratory, Department of Genetics and Molecular Medicine, Indiana University School of Medicine, Indiananpolis, IN, USA.
³ Indiana University School of Medicine, Indianapolis, IN, USA.
⁴ Indiana Institute for Personalized Medicine, Indianapolis, IN, USA.

No abstract available

Publication types

Research Support, N.I.H., Extramural

MeSH terms

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

Grants and funding