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  • 1.  Controlled correspondence query

    Posted 11-Feb-2023 04:08

    Hello all,

    We have submitted correspondence to fda and fda asking below comment:

    ''Please resubmit the controlled correspondence and include a statement in the cover letter that this controlled  correspondence is being submitted in connection with the development of a specific generic drug for a potential ANDA submission. Please refer to the Guidance for Industry - Controlled Correspondence Related to Generic Drug Development''. 

    Please suggest your thoughts to move forward.

    Regards,

    Sapna.



    ------------------------------
    sapna rathi
    Regulatory specialist
    AHME
    India
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  • 2.  RE: Controlled correspondence query

    Posted 12-Feb-2023 14:14

    Hi,

    OGD is very particular about the content of the controlled correspondences, and will reject them if the guidance isn't followed.  In the guidance they reference, there is a section called "Content of a Controlled Correspondence".  I follow this list, in order.  Also, include the cover letter attachment (from the guidance Dec 2021).  Without seeing what you submitted, I can't give you a specific answer, but based on the Agency's comment, it sounds like you need to add a sentence that addresses the following requirement:

    "Statement that the controlled correspondence is related to either a potential ANDA submission to OGD, an ANDA that is pending with FDA, an ANDA that received a CRL and is pending with the applicant, an ANDA that received a tentative approval letter, or an approved ANDA.
     − Provide the ANDA number, including whether the controlled correspondence is related to a potential ANDA submission to OGD that has already received a preassigned ANDA number."

    I would suggest revising the CC, and resubmit as a new CC.  Do not include the initial CC, as it was not received for consideration.

    Good Luck!



    ------------------------------
    Lisa Apolis, RAC
    Apolis Regulatory Consulting
    Georgia, USA
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    Original Message


  • 3.  RE: Controlled correspondence query

    Posted 13-Feb-2023 00:04
    Edited by Hemanth KG 13-Feb-2023 00:05

    Hi Sapna,

    I believe you might have missed to add a statement as commented by agency.

    I would suggest adding a statement and revise your controlled correspondence; "This controlled correspondence is being submitted in connection with the development of a generic drug i.e. (Mention your generic name) for a potential ANDA submission."

    I hope this helps. Thank you.



    ------------------------------
    Hemanth KG
    Senior Executive- Regulatory affairs CMC
    Bengaluru
    India
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    Original Message


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