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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.
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.
The DOJ’s recent report on FCA enforcement statistics for FY 2022 shows that while actions are dramatically up, recoveries are way down.
No company better embodies the vicissitudes of running a COVID-19-focused diagnostics business during the pandemic period than Lucira Health.
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.