The patient must have a or severely debilitating disease or condition.
The physician must contact the manufacturer to request the drug. Wait For Access
Complete and submit this form to the FDA to request individual patient expanded access. The patient must have a or severely debilitating
There is therapy available to treat the condition. the physician is responsible for:
Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access :
The potential benefit to the patient justifies the potential risks of the treatment.
It focuses on moving devices through the premarket review process faster if they demonstrate a breakthrough potential. Once access is granted, the physician is responsible for: