Expanded Access
What is expanded access?
Also known as “compassionate use,” expanded access is one pathway available for patients with serious or life-threatening conditions that allows them to access an investigational medical product outside of a clinical trial. These products may include drugs, medical devices, or biologics.
Expanded access may only be appropriate if all the following apply to a situation:
- The patient has a serious or immediately life-threatening condition or disease.
- The patient can’t be enrolled in a clinical trial.
- No comparable or alternative therapy of high enough satisfaction is available to diagnose, treat, or monitor the condition or disease.
- Providing the investigational medical product will not interfere with any investigational trials needed for the medical product’s development or marketing approval.
- The potential benefit of the investigational medical product to the patient justifies the possible risks.
How does expanded access improve healthcare?
Expanded access allows a patient with no alternative options access to a promising and potentially life-saving investigational medical product, even though the product has not yet received FDA approval. It offers hope when a patient otherwise has none and can significantly improve the patient’s health outcomes if the patient responds to the treatment favorably.