Expanded access, sometimes called “compassionate use,” is the use of an investigational medical product (one not approved by FDA) outside of a clinical trial.
The University of Wisconsin-Madison IRB is committed to using expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices.
Wherever possible, a patient’s use of an investigational medical product as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when a patient cannot be enrolled in a clinical trial (e.g., the patient is not eligible or there are no ongoing clinical trials), the patient may be able to receive the product, when appropriate, through expanded access.
Investigational New Device
See the IDE Expanded Access IRB Approval Process for:
- The IRB’s current expanded access investigational new device (IDE) policy
- Requirements for enrolling in expanded access IDE
- Steps investigators can take to get more information
Investigational New Drug
Contact IRBDirector@wisc.edu for IRB guidance on using expanded access Investigational New Drug (IND) with a single patient or a group of patients.