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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Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory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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Podrobná bibliografie
Vydáno v:J Clin Microbiol
Hlavní autoři: Caliendo, Angela M., Hanson, Kimberly E.
Médium: Artigo
Jazyk:Inglês
Vydáno: American Society for Microbiology 2016
Témata:
On-line přístup: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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