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    • QUI TAM (WHISTLEBLOWER SUITS)—D. Mass.: Relator had no evidence that Janssen infusion product programming violated AKS
    • CLINICAL RESEARCH—NOTICES: Design, safety considerations for clinical trials involving ibogaine drug products
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    • CONTROLLED SUBSTANCES—NOTICES: Wellwise Pharmacy Inc. registration suspended by DEA
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    • DRUGS AND BIOLOGICS—NOTICES: Pralidoxime chloride (autoinjector) solution was not withdrawn from sale for reasons of safety, effectiveness
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    • EXPERT INSIGHTS—D.C. Circuit Reaffirms Broad Reach Of The Anti-Kickback Statute And Confirms A Strict 60-Day Clock On HHS OIG Advisory Opinions
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    Health Law Daily Wrap Up, CLINICAL RESEARCH—NOTICES: Design, safety considerations for clinical trials involving ibogaine drug products, (Oct 8, 2026)

    By WK Editorial Staff

    The FDA will consider all information provided in response to this Request for Information (RFI) to inform whether and how these specific elements should be considered in its review of Investigational New Drug Applications (INDs) involving ibogaine.

    T ...

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