Expanded Access

Our mission is to accelerate access to investigational drug products for patients in need.

Also called “compassionate use,” expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. 

Expanded access may be appropriate when all the following apply:

  • Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.

  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

  • Patient enrollment in a clinical trial is not possible.

  • Potential patient benefit justifies the potential risks of treatment.

  • 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.

When investigational drugs, biologics or medical devices have not been approved or cleared by the FDA, our experts can assist in obtaining expanded access approvals.

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