TITLE

REGULATING PERSONALIZED MEDICINE

AUTHOR(S)
Kwon, Sarah Y.
PUB. DATE
January 2016
SOURCE
Berkeley Technology Law Journal;2016 Special Issue, Vol. 31, p931
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article examines the regulatory issues raised by the prospect of personalized medicine and legal and policy concerns over U.S. Food and Drug Administration (FDA) which regulate laboratory-developed tests (LDTs). It mentions that DNA sequencing technologies and diagnostic tests which compares the health care model. It also mentions that FDA's statutory authority over LDTs, the practice of medicine limitation, potential pre-emption by the Clinical Laboratory Improvement Amendments (CLIA).
ACCESSION #
120485591

 

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