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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic compan...

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Bibliographic Details
Published in:J Clin Microbiol
Main Authors: Caliendo, Angela M., Hanson, Kimberly E.
Format: Artigo
Language:Inglês
Published: American Society for Microbiology 2016
Subjects:
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4809918/
https://ncbi.nlm.nih.gov/pubmed/26791369
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1128/JCM.00063-16
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