The Food and Drug Administration (FDA) has provided potential pathways for patients who are suffering from serious or life-threatening diseases or conditions to access an investigational product for treatment outside clinical trials. There are separate pathways for investigational medical devices and investigational drugs/biologics. All expanded access pathways require both the IRB and Regulatory Affairs to be involved early on as the IRB may need to approve the study prior to use and a submission to the FDA may be needed prior to use. Please see the FAQs below for more detail.
