Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like

The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline wit...

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Detalles Bibliográficos
Autores principales: Marble, Hetal D., Bard, Adam Z., Mizrachi, Mark M., Lennerz, Jochen K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Investigative Pathology 2021
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444018/
https://www.ncbi.nlm.nih.gov/pubmed/34538703
http://dx.doi.org/10.1016/j.jmoldx.2021.07.011

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444018/
https://www.ncbi.nlm.nih.gov/pubmed/34538703
http://dx.doi.org/10.1016/j.jmoldx.2021.07.011

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