The physician must contact the manufacturer to request the drug.
This program allows for with the FDA during development to reduce time to market. Wait For Access
The patient must have a or severely debilitating disease or condition. The physician must contact the manufacturer to request
Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access : Wait For Access
If there is no time for the written form, a physician can request access via telephone or other rapid means.
There is therapy available to treat the condition.
Identify investigational drugs or devices that have shown promise in clinical trials but are not yet on the market.