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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
Bio-Reference Takes Steps to Publicize Dispute With New Jersey Blues
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Industry Buzz: Biodiagnostic: 17 Guilty Pleas and Counting
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MolecularHealth Aiming to Enter U.S. Market
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Mayo Clinic to Open New Stem Cell Lab
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Veracyte Plans Public Offering
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Health Diagnostic Laboratory Publishes Cost-Effectiveness Data
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Molecular Pricing Improves on Average, But Many Tests Not Priced at All
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