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.
As Congress Asks Theranos for Documentation, Its CEO Zigs to A Whole New Platform
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FDA Holds Exploratory Meeting on Liquid Biopsies
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FDA Issues Draft Guidelines for Companion Diagnostics
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FDA Seeks Public Comment on Blood Donor Deferral Policy to Decrease HIV Transmission
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FDA Approves Rapid Molecular Diagnostic Test for Detecting Antibiotic Resistance
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New FDA Draft Guidance Addresses Companion Diagnostics
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
FDA Workshops and Stakeholder Engagement Culminate in Draft Guidance on NGS-Based Testing
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New FDA Guidances Address NGS and Supporting Variant Databases
From - National Intelligence Report
Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidances last week addressing oversight of…
precisionFDA Challenges Support Innovation
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FDA Approval of First Liquid Biopsy Companion Diagnostic Furthers Rise of Non-Invasive Testing
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