RED 551 | Expanded Access to Investigational Drugs and Devices
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.
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