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- Title
FDA pushes for control over laboratory-developed tests.
- Authors
Ratner, Mark
- Abstract
The article offers information related to the urge of the U.S. Food and Drug Administration (FDA) to the U.S. Congress to enforce its oversight over laboratory-developed tests (LDTs) as of September 2014. It informs that the FDA is urging to regulate LDTs to reduce risk from rapid expansion of genotyping technology and widespread genomic testing. It also presents views of LDTs executive director Andrew Fish related to the issue.
- Subjects
UNITED States. Food &; Drug Administration; MEDICAL laboratory management; MEDICAL laboratories; MEDICAL laboratory use; FISH, Andrew; LABORATORIES -- Law &; legislation
- Publication
Nature Biotechnology, 2014, Vol 32, Issue 9, p855
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0914-855a