Regulatory Open Forum

Dear Colleagues,

If an open IND for a product exists in the US, but the  clinical study is being performed in Australia (no US sites) and the protocol was submitted to the IND for information only, is there any obligation to do safety reporting for individual cases to FDA from that Study (within 7/15 Days) or would annual reporting with DSUR/Annual Safety Report be sufficient?

 

Thank you!

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David Lucking
FL
United States
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Of course!!! The molecule safety in any part of the world should be submitted to the original IND in the US.

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GRSAOnline
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Original Message:
Sent: 01-Sep-2020 10:44
From: David Lucking
Subject: Safety Reporting

Dear Colleagues,

If an open IND for a product exists in the US, but the  clinical study is being performed in Australia (no US sites) and the protocol was submitted to the IND for information only, is there any obligation to do safety reporting for individual cases to FDA from that Study (within 7/15 Days) or would annual reporting with DSUR/Annual Safety Report be sufficient?

 

Thank you!

------------------------------
David Lucking
FL
United States
------------------------------