FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
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3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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A New Tool for Helping Labs Improve Diversity in Clinical Trials
Rachel Rangel, AuD, discusses a new toolkit to help laboratory professionals ensure diversity and inclusion is addressed in their research.
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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.
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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.
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FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
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FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
FDA Sounds the Warning on Use of Unauthorized SARS-CoV-2 Rapid Tests
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Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
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