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FDA's Expanded Access Program
FDA's Expanded Access Program
FDA's Expanded Access Program (also known as Compassionate Use) allows for the use of investigational drugs, biologics, or medical devices outside of the traditional clinical trial setting for treatment purposes. Expanded Access may be an appropriate avenue to pursue when the following apply:
1. The patient has a serious disease or condition or the patient's life is immediately threatened by their disease or condition;
2. There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition;
3. Patient enrollment in a clinical trial is not possible;
4. Potential patient benefit justifies the potential risks of treatment;
5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Expanded Access Categories
Expanded Access Categories
1) Non-emergency use: In a non-emergency situation, a written request (IND) for single patient use of an investigational drug must be submitted to the FDA. The investigational drug may be shipped and treatment of the patient may begin 30 days after the application is received by FDA or earlier if notified by the FDA that treatment may proceed. These non-emergency requests are known as individual patient INDs, or single patient expanded access requests.
2) Emergency use: life-threatening situation in which no acceptable standard treatment is available and in which there is not sufficient time to obtain full IRB approval. In an emergency situation, the request may be made via the telephone or other rapid means of communication.
Our Goal
Our Goal
Our goal within Vanderbilt Institute for Clinical and Translational Research (VICTR) is to guide the physician, patient, and drug company team through the Expanded Access/Compassionate Use process. The AIM team facilitates communication among key stakeholders and provides support through all phases, from inquiry to FDA application to delivery of the investigational agent. The intent of this infrastructure is to improve efficiency and minimize potential barriers to Expanded Access. To request AIM support for Expanded Access, click here or click on the AIM Support Request Form link below.
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