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    • FALSE CLAIMS ACT—S.D. Ohio: Relator failed to allege that there was anything illegal about referral exchange
    • AGENCY NEWS—HHS Settles With Dental Practice Over HIPAA Shortfalls
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    • AUDITS AND MONITORING—OIG REPORTS: South Carolina underreported federal share of collections subject to increased COVID-19 FMAP
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    • CONTROLLED SUBSTANCES—PROPOSED RULES: DEA proposes updates to scheduling actions for kratom products, derivatives
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    • DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: FDA issues guidance on postapproval manufacturing changes
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    • FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: AIDS Healthcare Foundation to pay $1.44M to settle FCA allegations
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    • FRAUD AND ABUSE—DAB DECISIONS: Health care fraud conviction supports 23-year exclusion
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    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Cal.: False advertising action concerning “naturally flavored” candy product may proceed in part
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    • MEDICAL DEVICES—FINAL RULES: Classification of the infant pulse rate, oxygen saturation monitor for OTC use
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    • MEDICAL DEVICES—FINAL RULES: Classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens, (Oct 14, 2026)

    By WK Editorial Staff

    The FDA believes the action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

    The FDA has classified the system for detection of nucleic acid from non-viral microorganism(s) causing sex ...

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