Compassionate use or expanded access is “a potential pathway for a patient with a serious or immediately life-threatening disease or condition 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. Investigational drugs, biologics or medical devices have not yet been approved or cleared by the U.S. Food and Drug Administration (FDA) and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.” (Source: U.S. Food and Drug Adminstration)
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