Regulatory Open Forum

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  • 1.  IND Submission Sections

    Posted 04-Oct-2018 12:17
    ​What is your experience in submitting only Module 2 or Module 3, not both, for the CMC information in a US IND?  Does the US FDA have issues with submitting only one of these?

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    Janet DeLeon RAC
    CEO
    Leawood KS
    United States
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  • 2.  RE: IND Submission Sections

    This message was posted by a user wishing to remain anonymous
    Posted 04-Oct-2018 13:40
    This message was posted by a user wishing to remain anonymous

    IND may be delayed especially if it is for an NCE. You are just taking a risk for the delay.
    Original Message


  • 3.  RE: IND Submission Sections

    Posted 05-Oct-2018 13:13
    Because of the level of detail in Module 2, I would hesitate to provide it alone - high risk.  ​I've seen INDs go in with just Module 3, with just a quick reference to Module 3 instead of a Quality Overall Summary.  No pushback from FDA (likely since all the info they would want to review was easily accessible in Module 3). 

    Personally, I like to include the QoS - it's a great opportunity to frame the information that goes into Module 3. 

    Best,

    Cathy

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    Catherine Anderson PhD, RAC
    Senior Manager - Regulatory CMC
    Hillsborough NC
    United States
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    Original Message


  • 4.  RE: IND Submission Sections

    Posted 05-Oct-2018 02:34
    The FDA only requires a Module 3 for an IND not a Module 2.3.

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    Meredith Brown-Tuttle, RAC, FRAPS
    President
    Regulatorium
    Santa Clara CA
    United States
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    Original Message


  • 5.  RE: IND Submission Sections

    Posted 05-Oct-2018 08:41
    I have never filed a CMC Module 2 summary in an IND - only a full Module 3.  In fact, I have experience with filing only a Module 3 to an NDA when it was for an uncomplicated substance and product.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 6.  RE: IND Submission Sections

    Posted 05-Oct-2018 11:04
    Dear Janet,
    As common practice, we only submit Module 2.3 or Module 3.2 for an early phase IND.  Typically, a note is included in the cover letter or a cover page for the section not included; the note states which section the CMC information is provided.  We have never had an issue with FDA asking for the section not submitted.  The information in the two sections is repetitive especially for a Phase 1 or 2 IND.  Duplicate information would just bog down the reviewer.   
    If you are entering Phase 3, then you may want to consider including both Module 2.3 and Module 3.2, as you are building your marketing application.
    Good luck!

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    Bridgette Kunst MA, RAC
    Managing Director
    Bridge Regulatory Affairs, LLC
    bkunst@bridgereg.com
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    Original Message


  • 7.  RE: IND Submission Sections

    Posted 05-Oct-2018 11:26
    ​Dear Janet,

    I agree with many folks who replied to this post. Yes the best practice is submitting only Module 3.2 or just module 2.3. We have done both, but its always good to have only Module 3.2 for early phase clinical trials. I know during early phase you might not have complete information in module 3 such process validation and full pharmaceutical development information. Its ok to add a single page documents describing this. Module 3 is living document and gets updated as new information is available.

    All the Best !
    SK

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    Regulatory Affairs Manager
    Pittsburgh PA
    United States
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    Original Message


  • 8.  RE: IND Submission Sections

    Posted 09-Oct-2018 17:16
    Hi Janet, 

    My experience has been similar to others, filing only the Module 2.3. However for a biologic product we have included both Module 2.3 and Module 3.2. 

    Kind Regards, 
    Ratinder

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    Ratinder Dhami
    Senior Scientific Advisor, Regulatory Affairs
    Network Partners
    www.networkpartners.com
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    Original Message


  • 9.  RE: IND Submission Sections

    Posted 05-Oct-2018 21:21
    Many Review Divisions will not require both M3 and M2.3 as M3 has a more complete description of the CMC information.  My suggestion is to contact your FDA Project Manager (or if a PM has not yet been assigned, the Supervisory PM) and inquire if the Division would accept M3 as a complete CMC section.

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    Mark De Rosch PhD, FRAPS
    Senior Vice President, Regulatory Affairs and Quality Assurance
    Nightstar Therapeutics
    Waltham, MA
    United States
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    Original Message


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