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  • 1.  Guidance for : Things to notify or submit after ANDA Approval

    Posted 29-Jun-2023 12:06

    Hi All,

    Once ANDA got approval, what things we need to initiate asap and submit /notify FDA.?

    Is there any specific guidance or portal through which we can do?

    Appreciate your feedback.

    Regards,

    Sapna.



    ------------------------------
    sapna rathi
    Regulatory specialist
    AHME
    India
    ------------------------------


  • 2.  RE: Guidance for : Things to notify or submit after ANDA Approval

    Posted 30-Jun-2023 11:01

    The FDA Guidance for Industry: Changes to an Approved NDA or ANDA, lays out what can be a notification (Annual Reportable) and what needs to be submitted (CBE-0 to PAS).  In addition, the Guidance "CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports" is more specific about what can be a notification.

    Hope this helps.



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    E David Murray PhD
    Consultant Regulatory Affairs
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    Original Message


  • 3.  RE: Guidance for : Things to notify or submit after ANDA Approval

    Posted 03-Jul-2023 09:31

    Hi Sapna,

    Your approval letter will provide some guidance if you have outstanding commitments and when they are due. It will also inform you of the deadline to eList your labeling. Other than what David mentioned, if you are not able to launch within 180 days, you need to notify the Agency - see guidance Marketing Status Notifications Under Section 506I of the Federal FD&C Act.



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    Ruth Collins RAC
    Manager Regulatory Affairs
    Fort Worth TX
    United States
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    Original Message


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