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  • 1.  IND - missing critical data (DP sterility)

    This message was posted by a user wishing to remain anonymous
    Posted 02-Dec-2021 14:26
    This message was posted by a user wishing to remain anonymous

    Dear all,

    Our company submitted an IND without critical safety data (Biologics DP sterility pending). Does anyone have experience with this situation? 

    Will we:
    1) get information requests from FDA asking for sterility data within the 30-day period and allow us to respond before the 30-day period ends?
    2) get a "clinical hold" decision near the end of the 30-day period due to the lack of sterility data?
    3) get a "partial clinical hold" decision near the end of the 30-day period due to the lack of sterility data?

    Thank you.




  • 2.  RE: IND - missing critical data (DP sterility)

    Posted 03-Dec-2021 08:52
    If FDA believes it is a safety issue - well, duh - you should get the request within the 30-day period and provide an opportunity to submit the data during the review. Assuming it is a clinical hold issue and you cannot respond within 30 days, I don't see any option other than a full clinical hold.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 3.  RE: IND - missing critical data (DP sterility)

    Posted 04-Dec-2021 09:29
    I agree with Glen and others about the clinical hold required by FDA (and all of us) for an IND/IDE when basic clinical safety data are missing. My question for you is why do this submission before the submission is ready? why shouldn't the FDA RTF (refuse to file) such a lame application which you KNOW is not ready? Isn't it reasonable to give the FDA a full 30 days to review  a full and complete application? My guess is you have many other deficiencies along with this one.

    We have done these partial applications many times and the FDA has almost always graciously accepted the burden and "trusted us" to deliver as promised, but I'm starting to feel like we should not be so self centered and demanding. This is especially true right now in the midst of this time when I believe all of us may be struggling with the work force, the poor quality of work products and the extended wait times for so many things.

    Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP

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    Original Message


  • 4.  RE: IND - missing critical data (DP sterility)

    This message was posted by a user wishing to remain anonymous
    Posted 03-Dec-2021 14:39
    This message was posted by a user wishing to remain anonymous

    Forget the FDA for a moment! Would you or your management is willing to dose a new biologic entity (i am assuming this is NBE) without a sterility assurance to a patient or healthy volunteer?
    Let me tell you my position, I wouldn't!
    Original Message


  • 5.  RE: IND - missing critical data (DP sterility)

    This message was posted by a user wishing to remain anonymous
    Posted 03-Dec-2021 14:39
    This message was posted by a user wishing to remain anonymous

    You will receive an IR from FDA asking for the data within the 30 day review period (and possibly a list of other questions/requests the FDA may have).  If you are unable to address all concerns presented in the IR, you most likely will be placed on clinical hold.  

    We had an instance where we did not include a relatively impactful piece of data with the initial IND application (human oversight) and proactively reached out to the assigned Regulatory Project Manager for assistance to ensure it reached the reviewers in a timely manner.  Doing so was beneficial to all parties as it helped to avoid the extra work of issuing and addressing an IR.
    Original Message


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