FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
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Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
LDT Regulation Appears to Be Stalled
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23andMe Ordered to Stop Marketing Genome Service
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Justice Department Sets Record in Fraud Recoveries
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Senator Questions ‘Conflicting’ HHS Policies On Patient Access to Lab Data
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CMS Proposes Hepatitis C Screening for Eligible Adults
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FDA Updates 2008 Guidance on Categories of Lab Testing
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AMP Expresses Concerns About Product Labeling in Letter to FDA
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Hospitals Urge FDA to Delay Final Guidance On Blood Glucose Monitoring Systems
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Stakeholder Group Calls for Reform of CLIA Waiver Process
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