Recent Conversations

  • RE: What FDA Regulations apply to drug-led drug/device combination ...

    Feb 27, 2026 11:42 AM
    Posted in: IRB Forum

    Thanks Harry. In our scenario, the autoinjector pen and the drug are being "manufactured" ...

  • RE: What FDA Regulations apply to drug-led drug/device combination ...

    Feb 27, 2026 11:39 AM
    Posted in: IRB Forum

    Thank you, Erin. This is helpful and clears it up for me. ------------------------------ ...

  • RE: What FDA Regulations apply to drug-led drug/device combination ...

    Feb 27, 2026 11:02 AM
    Posted in: IRB Forum

    If the autoinjector pen is considered a device constituent part of a drug-led ...

  • RE: What FDA Regulations apply to drug-led drug/device combination ...

    Feb 27, 2026 7:44 AM
    Posted in: IRB Forum

    My first question would be "Is the autoinjector FDA approved and is it used per ...

  • RE: Consent to repository when you know the specific study?

    Feb 26, 2026 4:47 PM
    Posted in: IRB Forum

    Hi Rebecca Would you say the repository protocol is providing a valuable ...

  • Use of Interpreters/Witness with Verbal Consent

    Feb 26, 2026 12:23 PM
    Posted in: IRB Forum

    The regs only talk about Witnesses for LES subjects on the written consent forms. ...

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