Submission. The expanded access submission must include information adequate to satisfy FDA that the criteria in 312.305(a) and paragraph (b) of this section have been met. The expanded access submission must meet the requirements of 312.305(b). In addition:
(1) The expanded access submission must state whether the drug is being developed or is not being developed and describe the patient population to be treated.
(2) If the drug is not being actively developed, the sponsor must explain why the drug cannot currently be developed for the expanded access use and under what circumstances the drug could be developed.
(3) If the drug is being studied in a clinical trial, the sponsor must explain why the patients to be treated cannot be enrolled in the clinical trial and under what circumstances the sponsor would conduct a clinical trial in these patients.