You don't need to withdraw your IND!!! Just transfer the IND holder from you (your company) to the Investigator!
See the detailed process below:
For the transfer to occur the new and former owners are required to submit the following information to the FDA:
1. A letter from the former owner stating that all rights to the application have been transferred
to the new owner (include effective date, IND #, new owner's name, address and contact
numbers) and that the new owner will receive or has received the complete IND files.
2. A letter from the new owner with the following:
- The new owner's commitment to agreements, promises, and conditions made by the
former owner and contained in the application;
- The date that the change in ownership is effective;
- A statement that the new owner has a complete copy of the approved IND application.
If necessary, the FDA will provide a copy of the application to the new owner under the
fee schedule in § 20.45 of FDA's public information regulations.
- A statement that the new owner agrees
a) to the promises and conditions made by the former owner, as well as to those
agreements, promises and conditions contained in the IND application
b) maintain a complete copy of the approved application, including supplements
and records that are required to be kept under 21 CFR 314.81
c) to amend the IND within 60 days to cover any and all changes in the IND that
result from the change in ownership
d) to provide subsequent changes by amendments in accordance with the IND
regulations
Also include the TORO and the following forms:
Form 1571
Updated Form 1572
CVs for the new investigators
Letter of support from the study drug manufacturer
IRB approval letter and approved ICF
Updated protocol with references to previous owner deleted and replaced with new owner.
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GRSAOnline
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Original Message:
Sent: 18-Jun-2023 21:59
From: Anonymous Member
Subject: Transfer of Sponsor for Drug Trials
This message was posted by a user wishing to remain anonymous
Hello,
We have a situation where there is a sponsored ongoing drug study (currently enrolling) that is not needed for the NDA. The sponsor can no longer fund or provide monitoring, etc. for the study.
The study needs to go from a sponsored study to an investigator-initiated trial. Can you transfer the sponsorship from the sponsor to the institution? Or would the sponsor need to withdraw the study and the investigator submit their own IND?
I know this is possible from sponsored study to sponsored study, or investigator-initiated trial to investigator-initiated trial, but I was unsure about switching sponsorship from a sponsored study to an investigator-initiated study.
Thank you for any help here, I really appreciate it! Any thoughts, comments, avenues are helpful as this is a unique situation :)