The process for gaining approval for intermediate size patient population expanded access involves several steps: 1. Request Submission: A formal request must be submitted to the FDA by the treating physician or the drug manufacturer. 2. Institutional Review Board (IRB) Approval: The treatment plan must be reviewed and approved by an IRB. 3. Informed Consent: Patients must provide informed consent, acknowledging the potential risks and benefits. 4. FDA Review: The FDA reviews the request and may ask for additional information or modifications before granting approval.
