Wait For Access Review

Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access :

The physician must contact the manufacturer to request the drug. Wait For Access

The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer. Before applying for early access, ensure the situation

Maintaining all required records and reports for the duration of the treatment. Before applying for early access

If there is no time for the written form, a physician can request access via telephone or other rapid means.