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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Labs In Court
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LabCorp Must Go to Trial to Defend against Deceptive Trade Practices Charges
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Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold
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The DX Pipeline: A Roundup of the Month’s Key New Product Launches
Here's a summary of the key product launches announced from late August through the third week of September, 2019:
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
Kickbacks: Medical Practices and Doctors Settlements for Accepting Millennium Freebies
In 2016, Millennium Health settled one of the largest lab kickback schemes ever concocted for $256 million. In September 2017, federal enforcers turned their attention to the practices that accepted bribes from Millennium in the form of...
