FDA perspectives on pharmacogenetic testing.
The field of pharmacogenetic testing is emerging as a topic of interest for many, due to its potential to improve patient care and optimize therapeutic development. The US Food and Drug Administration is interested in incorporating pharmacogenetics into development activities whenever appropriate to protect and promote public health. This article is intended to reflect the opinions of the Office of In vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health on some issues associated with developing in vitro diagnostic devices for use in pharmacogenetics. General points and potential issues related to the analytical and clinical validation of these types of devices will be discussed.
Harper
Courtney C
CC
Center for Devices & Radiological Health, Office of In Vitro Diagnostic Device Evaluation & Safety, US Food & Drug Administration, HFZ-440, 2098 Gaither Rd, Rockville, MD 20850, USA. courtney.harper@fda.hhs.gov
Philip
Reena
R
Robinowitz
Max
M
Gutman
Steven I
SI
D006262:Health; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*