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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
FDA LDT Regulation Could Affect 60,000+ Tests
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Presidential Election Campaign Sets Tone for 2017 Congressional Activity
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ACLA Uses Cancer Initiative to Lobby on PAMA, LDTs
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CMS Offers Long-Awaited Clarification of Deadline for Returning Overpayments
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Labs and Diagnostics Central to 2017 Federal Budget Requests
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Compliance Professionals Surveyed Name Cybersecurity and Social Media Top Compliance Concerns
From - G2 Compliance Advisor
Cyber security is a top compliance concern according to a survey of compliance professionals conducted by Health Care Compliance Association (HCCA) and the…
Indian Genomic Firm Acquires Lifecode Health
From - Laboratory Industry Report
LifeCode Health has been acquired by an Indian company that will use its assets as a foothold into the U.S. market…
2017 Federal Budget Highlights Precision Medicine and Fraud Enforcement
From - National Intelligence Report
Diagnostics figure prominently in key portions of the federal budget for Fiscal Year 2017. Significant funding is devoted to precision medicine, cancer, antibiotic resistance, and…
Lab Sector Jobs Grow by 25 Percent Over Last Decade
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