June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
Pfizer Acquires Lucira Health for $36.4 Million in Bankruptcy Auction
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
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
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
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.