Definitions for "EXPANDED ACCESS"
an FDA program that allows distribution of experimental drugs to people with life-threatening illness who have failed or cannot tolerate approved therapies, are unable to participate in clinical trials and have no other treatment options.
The mechanism by which FDA makes it possible for doctors to use investigational new products for gravely ill patients outside the context of a clinical trial and before a product has received marketing approval.
a program started by the FDA that allows certain promising investigational therapies available to people with serious or life-threatening illnesses and without other treatment options before their formal approval.