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FDA's draft guidance on laboratory‐developed tests increases clinical and economic risk to adoption of pharmacogenetic testing
Author(s) -
Levy Kenneth D.,
Pratt Victoria M.,
Skaar Todd C.,
Vance Gail H.,
Flockhart David A.
Publication year - 2015
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.492
Subject(s) - clinical pharmacology , medicine , family medicine , library science , medical education , pharmacology , computer science
The US Food and Drug Administration (FDA) notified Congress July 31, 2014,1 of its intent to regulate laboratory developed tests. These encompass thousands of clinical assays currently used in medical practice including most pharmacogenetic tests. This guidance has the potential to impact the innovation and sustainability of pharmacogenetic research and its clinical implementation.