FDA Watch - G2 Intelligence

FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition

HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.

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Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.

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Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.

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Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.

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A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.

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