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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
DOJ Report Reveals Fraud and Abuse Recoveries Declined in Fiscal Year 2015
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Make Sure Disciplinary Action Doesn’t Equal Retaliation
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News at a Glance – March 2016
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U.S. Lab Sector Globalizes with Foreign Deals
From - Laboratory Industry Report
For the better part of a century, laboratories had been among the most local of health care providers. But in recent decades, that dynamic has taken a 180-degree turn…
Second Doctor Indicted in Biodiagnostic Kickback Case
From - Laboratory Industry Report
Another physician has been indicted in the long-running Biodiagnostic Laboratory Services case. Bernard Greenspan, M.D., a family physician in Northern New Jersey, was indicted on…
Recent $3.9 Million Settlement and Task Force Announcement Focus Attention on Health Care Information Security
From - National Intelligence Report
A $3.9 million settlement arising from a potential HIPAA breach and an announcement regarding a U.S. Department of Health and Human Services Task Force emphasize the…
Transgenomic Announces Two New Tests for Colorectal Cancer, Melanoma
From - Laboratory Industry Report
Transgenomic has released two new liquid biopsy tests for colorectal cancer and metastatic melanoma…