If I understand correctly, the existing IND is "open" and studies were run under the existing IND. Then the previous sponsor filed an NDA which failed to receive approval.
As part of buying full rights to the prior IND, the old and new sponsors should execute a transfer of ownership of the existing IND from the old sponsor to the new sponsor. The process is described in 21 CFR § 314.72 Change in ownership of an application.
As to whether a new IND is needed for a new indication, this would depend on how similar are the old and new indications and whether the new indication would fall under a different reviewing division at FDA. If the new indication falls under a different reviewing division at FDA, a new IND is almost certainly required. If it falls under the same reviewing division as the old indication, FDA may allow it under the existing IND but note that FDA staffing is determined by the number of INDs they manage so there is a strong incentive for FDA to want new INDs.
Also consider whether you prefer to manage everything under the old IND or whether you would like to get a fresh start with a new IND.
You can submit the new pre-Phase 3 briefing package under the old IND and FDA will tell you if they want it under a new IND.
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William Sietsema
Vice President, Global Regulatory Affairs
Caladrius Biosciences, Inc
Rancho Santa Margarita CA
United States
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Original Message:
Sent: 23-Mar-2024 12:19
From: Anonymous Member
Subject: new IND required for different indication/sponsor?
This message was posted by a user wishing to remain anonymous
I have a client that has bought full rights to prior IND that failed to receive FDA approval. The new sponsor is changing the indication (more of a subset of original). Will a new IND be required and does this have to happen prior to obtaining a new Pre Phase 3 Briefing package? What else needs to be considered?