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  • 1.  DSUR for Multiple INDs

    Posted 15-Jan-2016 15:23

    Dear Members,

    Is it possible to submit 1 DSUR to the Initial (Mother) IND and cross-reference to other INDs with the same drug or should a DSUR be submitted to each IND?  Thanks for your assistance.

    Regards,

    David

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    David Lucking
    FL
    United States
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  • 2.  RE: DSUR for Multiple INDs

    Posted 15-Jan-2016 15:59
    A single DSUR is strongly recommended as it is intended to comprehensively analyze and present the safety profile of the drug including all indications, dosage forms, strengths, all patient populations, etc. 

    You may refer to Section II, FDA's E2F DSUR guidance. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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