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    • DRUGS AND BIOLOGICS—D.N.J.: Drugmaker loses cancer drug patent term extensions after missing statutory filing deadline by one day
    • ADMINISTRATION OF FDC ACT—NOTICES: Issuance of priority review voucher for Isembyld (apitegromab-mstn)
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    • CIVIL MONEY PENALTIES—DAB DECISIONS: Deficient monitoring of nursing facility resident’s amputation wound supported $12,760 penalty
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    • CIVIL MONEY PENALTIES—DAB DECISIONS: Notice of initial determination imposing a CMP did not extend deadline to request hearing as to findings of surveys
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    • CONTROLLED SUBSTANCES—NOTICES: Barry Backiewicz, D.D.S.; decision and order
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    • GENERAL HEALTH CARE NEWS—D.D.C.: FDA continues to reduce massive FOIA backlog, justifying more FOIA litigation stay extensions
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    • QUALITY OF CARE—OIG REPORTS: Nursing homes in 3 of 4 states reported challenges with implementing nursing home minimum spending requirements for resident care
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    Health Law Daily Wrap Up, CIVIL MONEY PENALTIES—DAB DECISIONS: Notice of initial determination imposing a CMP did not extend deadline to request hearing as to findings of surveys, (Oct 28, 2026)

    By Jeffrey H. Brochin, J.D.

    Petitioner did not request hearing to dispute findings of state agency surveys within 60 days as required by law, and therefore, only the issue of the amount of CMP imposed was considered timely appealed.

    The HHS Departmental Appeals Board (Board) Civ ...

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