This message was posted by a user wishing to remain anonymous
Hello,
I've seen several situations where the Sponsor decided to withdraw the application during the 30-days review and in my experience this has been done without any issue.
Also, in the majority of these cases, this was to avoid a Clinical Hold. FDA called the Sponsor to provide heads up that they were going to place the IND on hold, and the Sponsor decided to withdraw before getting the hold.
Kind Regards
Original Message:
Sent: 02-Feb-2023 08:06
From: Anonymous Member
Subject: IND withdrawl during the 30 day initial review period
This message was posted by a user wishing to remain anonymous
Hi folks - while I have seen a specific case of FDA requesting that a sponsor withdraw their IND during the initial 30 days review window, does anyone know if a sponsor can withdraw an IND during the 30 day review window (ie before the IND goes into affect)?
My assumption is a sponsor should be able to withdraw without any issues, but any experience doing so?