The potential benefit to the patient justifies the potential risks of the treatment.
There is therapy available to treat the condition.
The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer.
If there is no time for the written form, a physician can request access via telephone or other rapid means.
This program allows for with the FDA during development to reduce time to market.
The physician must contact the manufacturer to request the drug.
Physicians often have the most up-to-date knowledge on which manufacturers are developing new therapies. 3. Obtaining Manufacturer Authorization
Maintaining all required records and reports for the duration of the treatment.