[Anonymous]

Reply To: Expanded Access Label Requirements in the USA

Hi Darrin,

Thank you very much for your question. We sincerely apologize for the delay in responding.

It is not guaranteed the FDA will support the transition of patients from an open-label trial to an expanded access program. Therefore, we would first recommend that you consult with the FDA on your plans to transition your open-label patients to expand access.

Second, what type of expanded access program were you considering? Given you mentioned 3 patients, we would assume you are considering transition each patient to a Single Patient IND. Is this correct?
If so, you will be happy to learn there are no specific label requirements you have to adhere to for a Single Patient IND. You can easily divert material from an ongoing US clinical trial, to support your new Single Patient INDs.

If you are not going to leverage the Single Patient IND mechanism, please let us know.

Finally, if you have any additional questions regarding expanded access, please feel free to contact the GCSG Expanded Access Resource Team directly at eap@mygcsg.com. We are always happy to help with your expanded access needs.

Happy Holidays.

Cheers,
GCSG Expanded Access Resource Team