This message was posted by a user wishing to remain anonymous
My previous employer had this situation. While our main offices were in the U.S., the company was headquartered in another country. It was common for one of our foreign offices or subsidiaries to be the owner/sponsor of an IND and for one of our U.S. offices to be the agent for the IND, though we did all of the work on it in the U.S. offices. The only reason this was done was for tax purposes. If your company does not need the application to be outside the U.S. for tax purposes, then it would be better to transfer it. Suggest you check with your accounting/tax people on this issue.
Original Message:
Sent: 20-Dec-2018 10:32
From: Anonymous Member
Subject: IND Transfer
This message was posted by a user wishing to remain anonymous
I would think it would be more efficient and cost-effective for the US subsidiary to be the owner of the IND. It would allow them the ability to meet with FDA regarding the development program and would free up your Australian group to focus on country-specific matters. I would transfer the IND from the Australian subsidiary to the US subsidiary.
Original Message:
Sent: 19-Dec-2018 08:12
From: Anonymous Member
Subject: IND Transfer
This message was posted by a user wishing to remain anonymous
We are a small, start-up pharmaceutical company. Our headquarters is in China and we have several virtual global subsidiaries. Our Australian subsidiary is the sponsor of an IND. Our US subsidiary signs as the authorized representative on the Form FDA 1571. We have discussed transferring the IND ownership from our Australian subsidiary to our US subsidiary. Is there any advantage or disadvantage to leaving the Australian subsidiary as the sponsor of the IND?