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  • 1.  Protocols submission to Initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 12-Aug-2021 13:21
    This message was posted by a user wishing to remain anonymous

    Hi,
    We are submitting an initial IND application with nonclinical and clinical protocols 90 days before our first clinical study.  Are we allowed to ask  FDA questions related to the protocols? And will the FDA review and provide comments on the protocols?

    Thanks!


  • 2.  RE: Protocols submission to Initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 12-Aug-2021 14:18
    This message was posted by a user wishing to remain anonymous

    Please hire an experienced regulatory professional to help you with your initial IND. You don't ask questions when submitting an initial IND. You have 30-day FDA review for a new IND, if the FDA sees any clinical or partial clinical hold issues either with CMC or nonclinical (animal studies) or clinical phase 1 protocol, they will let you know right away within the 30 days!!! Submitting an IND is not a consultative submission!
    Original Message


  • 3.  RE: Protocols submission to Initial IND

    Posted 12-Aug-2021 21:18
    Agree with the response from the anonymous regarding filing of the IND. If you want feedback from the FDA on your pharm/tox, CMC or clinical sections, why not seek a Type B or C meeting prior to submitting the IND?

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    GRSAOnline
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    Original Message


  • 4.  RE: Protocols submission to Initial IND

    Posted 13-Aug-2021 08:19
    In agreement with other posts that if you have questions you will not get answers during an original IND submission review and should have a preIND meeting. Better to do it before submitting the IND rather than after.

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


  • 5.  RE: Protocols submission to Initial IND

    Posted 14-Aug-2021 11:26
    Agree, if you need FDA feedback on pharm/tox or clinical protocols for an upcoming IND submission the best way to achieve this is through a pre-IND meeting. To help provide additional context, the IND submission has a 30-day review clock and IF the FDA team has concerns or issues with your protocol, you will likely hear FDA concerns toward the end of the review clock (eg, after Day 23) which leaves very little time to reach agreement and implement the protocol revisions. IF you cannot or do not make requested protocol revisions and resubmit the protocol in time for FDA team to complete their review by Day 30, they will likely issue a clinical hold for the IND until the issue is satisfactorily resolved.

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    Deborah Tady RAC
    Exec Director, Global Regulatory Affairs
    Mission KS
    United States
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    Original Message


  • 6.  RE: Protocols submission to Initial IND

    Posted 14-Aug-2021 12:16

    Dear Anonymous, 

    Your question is odd. Typically, to file an IND you would have executed the required nonclinical studies to inform your clinical starting dose, identify potential safety profile and monitoring of the FIH dose, etc.   If you are filing the protocols, I am assuming the studies are executed and if you followed ICH depending on your molecule, it is likely too late to ask FDA questions anyway considering the timing of your IND. 

    I don't know if you are a public or private company, if you have announced a filing or if the timing of the IND a can be delayed. If the filing can be delayed, I would agree with others that requesting a Pre-IND type B meeting will help to get any questions answered. This strategy will mitigate delays to your study start if you file your IND without any discussions with FDA. Again, not knowing anything about your molecule, indication, etc. it's hard to advise. 

    if time is of the essence, I would file knowing you will get requests and questions and as already indicated could result in a clinical hold until resolved. Getting a clinical hold is not a great way to build a relationship with the Agency. Your CMC must also be robust and support the quality of the investigational agent. it could also result in a clinical hold due to CMC. 


    If you move forward with filing the IND, I would use the cover letter to make comments that cover the IND submission, for example, the nonclinical program followed ICH and based on Pivotal tox the dose was selected for the FIH. For clinical, a standard 3+3 dose escalation study is planned followed by an expansion to identify the MTD for selection of the  Phase 2 dose. Something like that. This is a higher risk strategy to clinical hold but again depends. 

    But to answer your basic question about the IND, totally agree with others that filing the IND means you meet all the requirements to initiate a FIH and FDA will review to ensure safe dosing of humans with product that meets quality requirements. If FDA is not able to conclude you are ready to initiate the study, and cannot review in 30 days, the may not accept the IND or it will be a clinical hold. 

    Hope this adds a bit more to the already good advise. 


    Dar



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    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
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    Original Message


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