When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum. Our expanded access program is one example. 

Expanded access is a pathway for a patient with a serious or immediately life-threatening disease or condition, and no comparable or satisfactory alternative therapy, to gain access to an investigational drug or biological product (i.e., one that is still being studied for safety and effectiveness to treat that disease or condition). Many patients may be able to obtain the investigational product by participating in a clinical trial testing the drug or biologic, but expanded access helps those patients who do not qualify for a clinical trial or otherwise cannot participate.

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