[Theresa Iacobucci]

Reply To: Single Patient IND Rolled Over from Clinical Trial – Supply Requirements?

Apologize for the delay in this response.
A patient can roll-over to a Single Patient IND, if the study is going to be closed. The patients must be transitioned to Single Patient INDs.
Can use the open-shared inventory and without applying ‘for compassionate use only’ auxiliary label. Since there are no formal requirements for the US only label, if open-shared inventory is not available, application of the ‘for compassionate use only’ auxiliary label in conjunction with striking the protocol reference could be done. This could also be managed with shipment documentation – denoted the supply for compassionate use only.

Please note that the new Single Patient IND/Expanded Access must be registered on CT.gov. (an oversight for many small biotechs) .
If there are any additional questions, please contact us again!