Expanded Access
Expanded access may allow a patient with a serious or immediately life-threatening disease to receive an investigational drug outside a clinical trial when applicable FDA criteria are met. Expanded access is not the same as participation in a clinical trial, and an investigational drug has not been approved by FDA as safe and effective for the requested use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected, serious side effects.
Expanded access may be appropriate when all the following apply:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
If you are a patient interested in possible expanded access to (Z)-endoxifen, please speak with your treating physician.
If you are a treating physician seeking information about Atossa’s expanded-access policy or a potential request for a patient, please contact us.