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.
Programs designed to make experimental drugs available on a wide basis to people who do not qualify for the clinical trials or who live too far from a trial site.
Procedures set forth by the FDA, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are not responding to currently available treatments for their condition and who are also unable to participate in other ongoing clinical trials.
Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
Programmes designed to make experimental drugs available on a wide basis to people who do not qualify for clinical trials, who live too far from a trial site, or who do not want to participate for any other reason.
a program that makes experimental drugs available on a wide basis to patients who don't qualify for a clinical trial. In most cases, a drug with an expanded access program is already in the final stages of the approval process. This program was started in 1987 by the U.S. FDA.
The ways that the FDA allows patients to get experimental medications outside of clinical trials before the drugs are approved. Compassionate use is one form of expanded access.
A method of distributing experimental drugs to patients who are unable to participate in clinical trials and have no other treatment options.
programmes that allow early access to drugs before they are approved for people who need them urgently (also called ‘early access’ or ‘named patient’).
The Canadian process for making some experimental drugs accessible to patients prior to licensing.