Making an Expanded Access Request

Click here to access and submit VUMC’s Expanded Access Medication Request form

This form may be used for both emergency and non-emergency Expanded Access requests.

  • Due to the urgent nature of emergency requests, if you are submitting after hours or on a weekend please call FDA’s emergency call center at 866-300-4374 to begin the process and notify the IRB of the impending emergency use by calling 615-322-2918 and selecting option #3.

Expanded Access Oversight Committee (EAOC) Review Process

In response to the steady increase in institution-wide Expanded Access requests, the EAOC was established in August 2024 to help promote transparency and streamline processes to continue to meet the needs of patients, providers, and other institutional partners across VUMC. The EAOC is charged with rapidly reviewing all non-emergency Expanded Access requests for appropriateness within the Expanded Access pathway and feasibility from an institutional perspective to ensure that clinical and pharmacy teams are appropriately resourced to support the request.  For more information, please see the EAOC charter linked here.