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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

June 2023 FDA Watch

June 2023 FDA Watch

by Glenn S. Demby | Jun 1, 2023 | FDA-lir, Laboratory Industry Report

So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.

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Pfizer Acquires Lucira Health for $36.4 Million in Bankruptcy Auction

Pfizer Acquires Lucira Health for $36.4 Million in Bankruptcy Auction

by Glenn S. Demby | May 9, 2023 | News

Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.

It’s Decision Day for Makers of FDA-Approved COVID-19 Tests

It’s Decision Day for Makers of FDA-Approved COVID-19 Tests

by Glenn S. Demby | Apr 25, 2023 | News

COVID-19 test makers will either have to get full marketing approval, or take the product off the market.

The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

by Glenn S. Demby | Apr 24, 2023 | Diagnostic Testing and Emerging Technologies, FDA-dtet

On March 27, the agency released a new guidance document to help test developers make the transition to full approval.

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

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

by Glenn S. Demby | Mar 30, 2023 | FDA-lir, Laboratory Industry Report

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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