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A DSUR is different than an AR. You can submit either, but I believe once you choose to submit DSUR you must stick with DSUR going forward and can't go back to AR. You had only mentioned AR in your original post and I agree with the response that a 1-pg AR is acceptable explaining no activity. But if you submit DSUR you'll likely have to provide a little more info to address each section of DSUR - even if there's been no activity for that section.
Original Message:
Sent: 14-Dec-2023 21:31
From: Anonymous Member
Subject: Annual report
This message was posted by a user wishing to remain anonymous
Thank you for the comment. It seems that AR will require more information in the future. Federal Register :: Investigational New Drug Application Annual Reporting..
Can we still submit a brief one page AR "nothing to report" as a replacement of DSUR?
Original Message:
Sent: 13-Dec-2023 09:53
From: Anonymous Member
Subject: Annual report
This message was posted by a user wishing to remain anonymous
"Can we use the CSR alternative information of annual report?" No! AR, even if its one page saying nothing to report, just submit it! CSR as an amendment to IND separate submissions.
Original Message:
Sent: 12-Dec-2023 16:39
From: Anonymous Member
Subject: Annual report
This message was posted by a user wishing to remain anonymous
Dear All,
I have a question about annual report responsibility. IND is going to be dormant soon. However, annual report due is coming before the timing of IND status change. Do we have an obligation to submit the annual report during the reporting period (IND was active)? The reason of IND inactivation is not safety reason. We are preparing the study CSR. Can we use the CSR alternative information of annual report? Please advise.