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More than 90 test developers have sought FDA guidance for tests they plan to offer through the EUA process
March 18, 2020
By: Tim Wright
Editor-in-Chief, Contract Pharma
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 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 ...
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