IND: Transfer of Ownership
The investigator who holds an IND may transfer the IND to a new owner. This may be necessary when the Sponsor-Investigator is leaving the university or no longer has the resources to fulfill Sponsor -Investigator responsibilities.
In order to transfer the IND, both the new and former owners are required to submit information to the FDA. This includes a letter from the former owner stating that all rights to the application have been transferred to the new owner and that the new owner will receive or has received the complete IND record. The new owner also needs to submit a letter agreeing to accept the IND & along with the new owner’s commitment to agreements, promises, and conditions made by the former owner and contained in the application. Additional specific forms required are listed in the checklist below.
To help you with the transfer process, please click the links below:
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