Ann Johnson, Ph.D Director Institutional Review Board
This is a REd Asynchronous (online/self-paced) class.
The Food and Drug Administration (FDA) Expanded Access Program allows for investigational
drugs and devices (i.e., non-FDA approved) to be used for treatment outside of a clinical
trial. While such treatment use is not considered a clinical investigation, FDA submission
and Institutional Review Board (IRB) review are necessary.
This presentation will discuss the criteria for evaluating and securing FDA Expanded
Access Program approval for investigational drugs and devices. The required FDA protocols
and IRB procedural steps that must be followed for individual patients, intermediate-size
patient populations and large patient populations will be described.
REd Asynchronous classes feature lessons and exercises designed to build competency and increase efficiency.
Modules are accessible 24/7 and are all self-paced. All members of the University
research community are invited to complete any online classes of interest.