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  • 1.  Approved NDA -PSG guidance not available for ANDA development

    Posted 03-Feb-2023 05:18
    Dear All,

    For already approved NDA, no ANDA in market, PSG guidance not available and we want to develop ANDA for the same.

    what will be suitable option to move ahead:
    1. Controlled correspondence
    2. Suitability petition
    3. Pre-ANDA programme/meeting

    Please suggest to move forward.

    Regards,
    Sapna

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


  • 2.  RE: Approved NDA -PSG guidance not available for ANDA development

    Posted 04-Feb-2023 11:21
    Hi Sapna,
    It depends on the drug product and the dosage form - is this a complex product? an oral dosage form?  Injectable?  Long-acting?  There is quite a bit of information out there for oral dosage forms, but not so much for others.  I would suggest looking at the PSG database for a similar product, and see what is required, then develop a BE strategy and submit a Controlled Correspondence to get OGD's input.  If you propose something completely different from what other similar drugs require, then a Pre-Development meeting request would be helpful, but I would start with a CC.

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


  • 3.  RE: Approved NDA -PSG guidance not available for ANDA development

    Posted 07-Feb-2023 06:11
    Hi Lisa,

    Thank you so much for your response.

    We have done cc to fda and get response from fda that we need to check PSG page for updation. which will take 2 -3 years to publish guidance .

    Can you suggest  what we can do next?

    Regards.
    sapna

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

    Original Message


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