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  • 1.  DSUR question

    Posted 16-Mar-2016 11:38

    My company has a few INDs that do not have any activity, but we want to keep these INDs "active".  Prior to 2012 when my company was submitting IND Annual Reports, we would simply submit a cover letter that served as the IND Annual Report.  The letter would state there was no activity during the reporting period.  Since 2012 we have switched from submitting IND Annual Reports to Development Safety Update Reports (DSURs).  My question: if there was no activity during the reporting period, can we just submit a cover letter that serves as the DSUR – just as we did when we were submitting IND Annual Reports?  Or do we need to submit a complete DSUR?  The FDA Guidance on DSURs does not speak to this.

     

    Thank you

    Tom

    Chicago



  • 2.  RE: DSUR question

    Posted 16-Mar-2016 12:21
    Tom,

    I provide extensive training services to the global audience. 

    "My question: if there was no activity during the reporting period......Or do we need to submit a complete DSUR?  The FDA Guidance on DSURs does not speak to this."

    In response to your question above, in both the US and EU, the DSURs, submitted annually, can take the place of the IND annual report and EU annual safety report.  Yes, a complete DSUR (all sections) should be submitted but please state "no info is available" under the relevant sections. 

    When doing so, you can also indicate your coming year plan (e.g., keeping them active) under the section "region specific info." 

    Please refer to the FDA DSUR guidance at pages 1 and 8. 

    Thank you.  

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



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  • 3.  RE: DSUR question

    Posted 24-Mar-2016 22:24
    Edited by Prakash Patel 24-Mar-2016 22:25

    Hi David, 

    I agree with your comments. I am primary liaison to carry out Annual Report for IND/NDA/BLA submissions. While processing ARs in daily basis, I do submit an entire IND Annual Report even though there is no clinical pharma or clinical trial conducting. I simply indicate there is no update took place in reporting period in all 9 sections. On the other hand, every new IND we are filing, we are requesting FDA to give waiver of submitting DSUR instead whole Annual Report.

    Tom, I do want to ask you questions. Is it possible to convert DSUR for legacy products? These are products which have been approved in early 90s and 2000. 

    Thanks, 

    ------------------------------
    Prakash Patel
    Sr. Regulatory Submission Management
    Roche (TCS)
    Midland MI
    United States

    Original Message


  • 4.  RE: DSUR question

    Posted 25-Mar-2016 13:11

    Hi Prakash

     

    Yes, you can switch from an IND Annual Report to a DSUR for older INDs.  You just can't switch back to IND Annual Report after switching to DSUR.  You don't need FDA approval for switching to DSUR, but you should mention in your cover letter that you are switching to DSUR.  If you have multiple INDs for the same compound, I would recommend you align the reporting dates for all INDs so you only have to submit one DSUR.  You do need FDA approval to re-align reporting dates.

     

    Tom

     

     

     

     




    Original Message


  • 5.  RE: DSUR question

    Posted 25-Mar-2016 16:34
    Hi Tom and Prakash,

    Great Day!

    Tom: thank you for putting my name as a recipient (addressed or posted to) in Prakash's response post.

    Prakash: thank you for sharing your current practice and further for agreeing with my comments. 

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



    Original Message