Regulatory Open Forum

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  • 1.  protocol exclusion

    Posted 21-Aug-2012 08:57
    Dear colleague,

    I need to excluse a protocol from an IND since we do not intend to use the data for approval.  How do I go about doing this?  What kind of information will the FDA ask or can I just exclude the protocol.

    Thank you for your help in this matter.

    Regards,

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    Esther Hendrickson, MISM
    Manager, Regulatory Affairs
    LICR
    New York NY
    United States
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  • 2.  RE:protocol exclusion

    Posted 03-Sep-2012 09:45
    if the sdtudy is being ocnducted in the US it is not possible to exclude it from the IND.  The IND provides permission to conduct investigational research in the US.  if you do not intend to use the data you will need to discuss with FDA.  if you do not plan to use the data, why conduct the study?

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Moriah Consultants
    Yorba Linda CA
    United States
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    Original Message


  • 3.  RE:protocol exclusion

    Posted 04-Sep-2012 19:50
    An IND is required to conduct a clinical trial of an investigational drug in the US.  Exemptions from this requirement are described in 21CFR Part 312.2.  One of the criteria for an exemption is that the data are not intended to be used to support FDA approval, but there are a number of other criteria for an exemption, and ALL of them must be met.  Otherwise, the study must be conducted under an IND.


    Julie Omohundro RAC
    RAQA Services
    Research Triangle Park NC
    United States


    Original Message


  • 4.  RE:protocol exclusion

    Posted 08-Sep-2012 21:02
    Esther,

    Although I am not certain, it sounds like you are looking to be granted an exemption from the IND regulations for a clinical protocol.  This is possible when you are performing clinical studies with marketed products (usually in an indication not yet approved).  If so, the process to be followed and the criteria used by FDA are described in 21 CFR 312.2.  Furthermore, it appears that you work in the Cancer field.  FDA issued a specific guideline on exemptions for lawfully marketed products for cancer: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071717.pdf.

    I suspect that this will provide the information you need to determine whether the study you are proposing would be exempt from IND requirements.

    If you need any further guidance, please contact me.

    Regards,
    Mark

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    Mark Ammann PharmD
    President
    Catalyst Regulatory Services, LLC
    Dexter MI
    United States
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    Original Message