HHS tells FDA to resume expedited review lab-developed COVID tests

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The HHS move appeared to be inspired by the pandemic, with the department noting that its recission of FDA guidances and other informal issuances concerning premarket review of LDTs was “part of HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.”

The HHS move appeared to be inspired by the pandemic, with the department noting that its recission of FDA guidances and other informal issuances concerning premarket review of LDTs was “part of HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.”

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