The FDA and genetic testing: Improper tools for a difficult problem

Abstract:

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDAregulation in...

Type:
Journal Article
Date:
Authors and Contributors:
Kirk Willmarth
Pages:
158-166
DOI:
10.1093/jlb/lsv002
Issue:
1
Volume:
2
Publication:
Journal of Law and the Biosciences
LawSeqSM Record Last Modified:
08/13/2018