Category: IVD

  • HHS STI Plan

    HHS STI Plan

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    by

    Lori
    in ,

    The U.S. Department of Health and Human Services (HHS) Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC: U.S. Department of Health and Human Services; 2020 cites the need for innovative solutions and approaches to address the ongoing and emerging challenges to Sexually Transmitted Infections (STI) prevention and control, including expanding…

  • CDISC SDTM Mapping

    CDISC SDTM Mapping

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    by

    Lori
    in , , ,

    Introduction Timely, clear and actionable data insights allow important clinical decisions to be made in real time. And earlier insights mean life-changing or life-enhancing medicines can be brought to those in need faster. When it comes to clinical trials, data is everything. Data analytics answers questions like Is a drug working? Do side effects exist?…

  • SR and NSR Considerations

    SR and NSR Considerations

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    by

    Lori
    in ,

    Investigational IVD research sponsors (and sponsor-investigators) need to make SR/NSR device determinations and provide study-specific justification for their assessment to institutional review boards (IRBs). Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements (21 CFR 812). Unless the study meets certain IDE exemption…