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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
OIG Analyzes 2014’s Top 25 Laboratory Tests
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ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress
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FDA Paves a Path for Some DTC Genetic Tests; Challenges Others
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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AltheaDX Raises $30 Million, Announces New Tests
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Laboratory M&A in 2015: Flat but With Possibilities Moving Forward
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Two Prominent Senators Push CMS to Make Changes on PAMA Rules
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Sequenom Remakes Fiscal, Operational House
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