FDA told to resume expedited review of lab-developed COVID tests

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The HHS move appeared inspired by the pandemic, with the department noting that its rescission of FDA guidance for premarket review of lab-developed tests was part of an ongoing regulatory review in the wake of COVID-19.

The HHS move appeared inspired by the pandemic, with the department noting that its rescission of FDA guidance for premarket review of lab-developed tests was part of an ongoing regulatory review in the wake of COVID-19.

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