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  • 1.  3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment

    Posted 09-Dec-2022 18:27
    Dear community,

    For IND, does the sponsor needs to write anything in M 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment? 

    Thank you.

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    Hua Jin
    United States
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  • 2.  RE: 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment

    Posted 10-Dec-2022 07:25
    No

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    Gregory Wei
    Middleboro MA
    United States
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    Original Message


  • 3.  RE: 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment

    Posted 10-Dec-2022 09:10
    No-that section is for after approval of the drug. for our iND you typically don't have any post approval commitments

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    Cheryl Rowe-Rendleman
    Dr
    Durham NC
    United States
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    Original Message


  • 4.  RE: 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment

    Posted 10-Dec-2022 15:16
    No. This is not a requirement for INDs. We don't submit a 32P82 section. But the protocol for your development/clinical batches should be presented in 32P81.

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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


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