Today, the U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
“Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January -- providing technical assistance to test developers to help facilitate the...
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