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Expanded Access to an Investigational Medical Product

key information

source: Food and Drug Administration

year: 2019

summary/abstract:

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available.
 
Investigational medical products are investigational drugs, biologics or medical devices that are being tested to see whether they are safe and effective. This means that these products have not yet been approved or cleared by the FDA and the 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 serious side effects that were not expected.
 

When seeking expanded access to an investigational medical product, it is critical that you and your licensed physician (typically your doctor, but not all doctors or healthcare providers are licensed physicians) consider all possible risks.

 

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