1) The DIBD is the date that the active substance was first cleared for clinical investigation by a regulatory authority. So, if first cleared by FDA then it would be the "primary" IND.
2) Since the DSUR will cover all INDs, which I assume are for different dosage forms and/or indications, the DSUR should be submitted to all INDs that include the active substance.
3) The timing of updating the IB is dependent on the timing of clinical studies and when the new safety data needs to be reflected in it. Typically, it works to update annually at the time of the DSUR, but if the IB has already been updated and there is no new safety data to include the IB does not have to be updated again just for the DSUR. Since the updated IB will probably have been already submitted to FDA it does not have to be submitted again with the DSUR.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 20-Sep-2019 16:17
From: Anonymous Member
Subject: One DSUR for All IND's with Same Investigational Drug
This message was posted by a user wishing to remain anonymous
Hello RAPS Community,
I understand that the Guidance for Industry: E2F Development Safety Update Report Section 2.1 states that sponsors should submit a single DSUR for an an active substance, the "Development International Birth Date* (DIBD) is used to determine the start of the annual period for the DSUR," and the "data lock point of the DSUR should be the last day of the one-year reporting period."
Questions:
1.) If one submits a single DSUR for an active substance and there are multiple IND's that utilize the same active substance, how does one determine the "DIBD" and "data lock point" for the multiple IND's? Is it determined based on the primary IND?
2.) For the other IND's that cross-reference the primary IND, must one notify the FDA to refer to the DSUR submitted for the primary IND?
3.) As a part of the DSUR process, must one also update the IB annually to reflect the updated safety data or is it optional?
I hope the questions make sense - any guidance is appreciated. Thank you!