1. Physician Request: The patient's physician must determine if compassionate use is the best option and then contact the manufacturer of the investigational drug. 2. Manufacturer's Agreement: The drug manufacturer must agree to provide the investigational drug for compassionate use. 3. Regulatory Approval: The appropriate regulatory body, such as the FDA in the United States, must approve the use of the drug for compassionate use. 4. Institutional Review Board (IRB) Approval: An IRB must review and approve the compassionate use request to ensure patient safety.
