Expanded access, also known as compassionate use, is a process by which a patient can request both the manufacturer of an experimental product (treatment) and the US Food and Drug Administration for access to the treatment outside of a clinical trial. Desperately ill patients, family caregivers and treating physicians often consider this option, but navigating the process to gain access can be confusing.

Now a tool, the Reagan-Udall Foundation Navigator, offers information regarding the required steps for application.  It was developed for oncology treatments with an intention of extending it to other diseases and treatments. Physicians and patients alike can learn about the process and locate necessary information for application by following the specified sections—one for physicians and one for patients.

To learn more about the IRB portion of the application, go to https://clinicalresearchpathways.org/irbs/
You can also contact WCGF directly at info@wcgfoundation.org.

For more information about the Reagan-Udall Expanded Access Navigator, go to http://navigator.reaganudall.org/