UNDERSTANDING “EXPANDED ACCESS”
Information about the FDA’s current expanded access policies, requirements for enrolling in expanded access programs, and steps you can take to get more information:
Expanded Access is a potential pathway for a patient with an immediately life-threatening or serious 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.
(See FDA page: Expanded Access)
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