Urine Drug & Genetic Testing Remain Top Enforcement Targets
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
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Lab Owner Charged in Latest COVID-19 Fraud Crackdown
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
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.
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Senators to HHS: Keep Covering At-Home COVID-19 Tests After PHE Ends
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.