FDA Issues Notice to Rescind Laboratory Developed Test Rule
The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.
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Search Results for: compliance
Quanterix Accelerator Laboratory Gains New York State Clinical Lab Permit
The CLIA-certified facility is now authorized to operate in all 50 states, expanding biomarker testing capabilities nationwide.
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New Guidance on Modifications to Antimicrobial Susceptibility Testing
The new document provides framework for drug developers on appropriate use and modification of reference AST methods during antimicrobial development.
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Bio-Rad Launches Unity Next Peer QC Software in Asia-Pacific
Cloud-based quality control data management platform aims to reduce costly reruns and streamline QC reporting workflows.
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DocVilla Integrates with AccuReference Medical Lab for Direct EHR Connectivity
The cloud-based EHR platform now offers real-time lab ordering and results delivery, eliminating the need for separate portals or fax-based communication.
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