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.
FDA Approves First Liquid Biopsy Companion Diagnostic for Lung Cancer
From - National Intelligence Report
Roche announced last week that the U.S. Food and Drug Administration (FDA) approved the cobas® EGFR Mutation Test v2 "for use with…
FDA Releases Draft Guidance for NGS-Based Tests for Infectious Disease Diagnosis
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House Appropriations Bill Seeks to Halt FDA Regulation of LDTs
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First Commercial Lab Gets FDA Emergency Clearance for Zika Test
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Culture-Independent Tests Gain Clinical Traction, Hamper Public Health
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Update: Federal Agencies Accelerate Preparations to Combat Zika Virus in the U.S.
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U.S. Government Begins Prepping Battle Against Zika with National Summit
From - National Intelligence Report
With spring and mosquito season rapidly approaching, concern about and the fight against the Zika virus is heating up. Today, a press conference will be…
FDA Challenges DTC Genomic Tests from Startup Labs
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New FDA Approvals, Guidelines and Letters Address Zika Testing
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AACC Weighs in on Regulation of Laboratory Developed Tests
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