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- Title
REGULATING PERSONALIZED MEDICINE.
- Authors
Kwon, Sarah Y.
- 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).
- Subjects
INDIVIDUALIZED medicine; UNITED States. Food &; Drug Administration; NUCLEOTIDE sequencing; ROUTINE diagnostic tests; MEDICAL care; PRE-emption; MEDICAL laws; LAW
- Publication
Berkeley Technology Law Journal, 2016, Vol 31, p931
- ISSN
1086-3818
- Publication type
Article
- DOI
10.15779/Z38Z26X