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Instructions:1. Use this consent template for Single Patient Expanded Access only. Please refer to the Expanded Access and Emergency Use of a Test Article (Drugs, Biologics and Devices) guidance available
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Expanded access, also known as compassionate use, allows patients with serious or immediately life-threatening medical conditions to gain access to investigational drugs, biologics, or medical devices outside of a clinical trial when no comparable or satisfactory alternative therapy options are available.
Healthcare providers, patients, or their legal representatives are required to submit a request for expanded access.
The request for expanded access can be submitted through the FDA's Expanded Access Submission Portal online.
The purpose of expanded access is to provide patients with access to investigational treatments that may help their medical condition when other options have been exhausted.
The request must include information about the patient's medical condition, the investigational treatment being requested, and justification for why expanded access is necessary.
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