Expanded Access Drug and Device Submissions

Expanded Access pathways offer patients with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of a clinical trial when there are no comparable or satisfactory alternative therapy options available.  Expanded access pathways include Emergency Use, Single Patient access, and Treatment protocols under an IND or an IDE.    

Physician Responsibilities

When requesting expanded access use, physician responsibilities include agreeing to oversee the patient’s treatment, working with the medical product developer for approval to use the medical product, filing paperwork with the FDA and the IRB, responsibility for ongoing patient care, and ensuring compliance with the treatment plan, GCP, local, and federal regulations.  FDA reporting requirements are the same for expanded use applications as they are for full IND and IDEs.  

We have developed an eIND packet with processes, guidelines, and templates to expedite emergency use applications, and have identified key personnel within the University that will need to assist with the process, to ensure that these requests are expedited and can be processed and approved quickly.  This packet will be provided once the IND/IDE Specialist has been notified of the emergency use request.