Emergency Use/Expanded Access

Version Date: March 2020

Expanded access is a potential pathway allowed by the FDA for a patient with an immediately life-threatening condition 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. Expanded access can involve an individual patient, or a group of patients. The IRB has the following guidance available for treating teams.

Please contact IRBdirector@wisc.edu with questions.

Emergency Use/Expanded Access Guidance

Keywords:emergency use, FDA, drug, biologic, device   Doc ID:99033
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-03-18 05:44 CDTUpdated:2020-03-18 08:45 CDT
Sites:Health Sciences IRBs
Feedback:  0   0