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  • 1.  Is CRF must be submitted in ANDA?

    Posted 30-Sep-2015 11:11

    Dear all,

    1. We don't have any CRF's for deaths, other serious adverse events, and withdrawals for adverse events for this study but how to understand 16.3.2------ Other CRF's submitted? Does this mean all other normal CRFs? In this case, do we need to submit our normal CRFs?

     

    2. 16.2.8 Listing of individual laboratory measurements by patient, when required by regulatory authorities.

    For above, it is not necessary to submit in filing only when required by FDA, right? Please confirm. Because our consultant ask us to submit this.

     

    Thanks so much!

     

    ------------------------------
    Jingyang
    Downingtown PA
    United States
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  • 2.  RE: Is CRF must be submitted in ANDA?

    Posted 01-Oct-2015 11:22

    Is there any one can help me with these? Appreciate it!

    ------------------------------
    Jingyang Zhu
    Downingtown PA
    United States
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    Original Message


  • 3.  RE: Is CRF must be submitted in ANDA?

    Posted 01-Oct-2015 15:02
    Jingyang,

    Your normal CRFs should be put under 16.1.2.

    Under 16.3.2., you may indicate "Not Applicable or N/A," if not applicable.

    Other "CFRs submitted" include vital signs.   Please note: The language "Other CRFs Submitted" is not expressly defined.  

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 4.  RE: Is CRF must be submitted in ANDA?

    Posted 02-Oct-2015 09:32

    David,

    Thanks for your help. But do i need to put all my normal CFRs under 16.1.2? What i thought was just put only one blank CRF  under that since it is "Sample case report form (unique pages only)." . Thanks again!

    ------------------------------
    Jingyang Zhu
    Downingtown PA
    United States
    ------------------------------


    Original Message


  • 5.  RE: Is CRF must be submitted in ANDA?

    Posted 02-Oct-2015 12:34
    Jingyang,

    Not necessary to provide all your normal CRFs (Not CFRs) although it is recommended to do so.

    Under 16.1.2, you may put "sample case report form" and then BELOW it.

    You may create a sub-section and provide all your normal CRFs although not necessary!

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 6.  RE: Is CRF must be submitted in ANDA?

    Posted 02-Oct-2015 15:41


    David,

    I appreciate all your help and have a nice weekend!

    ------------------------------
    Jingyang Zhu
    Downingtown PA
    United States
    ------------------------------


    Original Message