FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
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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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FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
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EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
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Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
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Harmonizing Device CGMP Requirements with International Standards
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A Big Step for CRISPR-Based SARS-CoV-2 Test
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Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests
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HHS Restores Agency’s Premarket Review of LDTs
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Agency Takes Steps to Promote Scientifically Sound Development of AI-Based Medical Devices
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Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations
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Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
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