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The Post Expanded Access Drug and Device Submissions

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 Investigational New Drug (IND) or an Investigational Device Exemption (IDE). 

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 U.S. Food and Drug Administration (FDA) and the Institutional Review Board (IRB) 
  • Ongoing patient care 
  • Ensuring compliance with the treatment plan, Good Clinical Practice (GCP), local, and federal regulations 

FDA reporting requirements are the same for expanded use applications as they are for full IND and IDEs.  

Please see the CRSO IND/IDE website for additional information, working guidelines, and eIND video. 

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