According to the FDA’s published guidelines, compassionate use may be appropriate when all the following apply:
Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
The patient cannot get the medical product under another investigational medical product study or protocol
The possible benefits to the patient justify the possible risks of the treatment, and those possible risks are not unreasonable given the disease or condition to be treated
Providing the investigational medical product will not interfere with the clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access product
