Which patients qualify for Expanded Access?

Qualifications for Expanded Access

(as per federal regulations, CFR Title 21):

  1. Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition;
  2. Patient has no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the their disease or condition;
  3. Patient enrollment in a clinical trial is not possible;
  4. Potential patient benefit justifies the potential risks or treatment;
  5. Providing the investigational medical product will not interfere with clinical trials that could support a medical product’s development or marketing approval for the treatment indication.

Click here to request AIM support in pursuing Expanded Access use of an investigational therapy.

For emergency requests, please call (615) 322-2918 and select option #3.