Wait For Access (2024)
Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access :
The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer. Wait For Access
If there is no time for the written form, a physician can request access via telephone or other rapid means. Before applying for early access, ensure the situation
This program allows for with the FDA during development to reduce time to market. Before applying for early access
