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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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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A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
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Congress Retables VALID and VITAL Legislation to Regulate LDTs
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FDA Pulls the Plug on EUA Review of COVID-19 LDTs
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Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs
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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From – Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory