Expanded Access & Project Facilitate
When standard treatments aren't working and clinical trials aren't an option, you may be able to access investigational drugs through the FDA.
What is Expanded Access?
Expanded Access (also called "compassionate use") is an FDA program that allows patients with serious or life-threatening conditions to access investigational drugs, biologics, or medical devices that haven't yet been approved — when:
- No comparable or satisfactory alternative treatments exist
- Enrollment in clinical trials isn't possible
- The potential benefit justifies the potential risks
Important: Investigational products may or may not be effective and may cause unexpected serious side effects. This is a pathway when other options have been exhausted.
Project Facilitate
FDA's Oncology Expanded Access Support
Project Facilitate is a dedicated FDA program specifically for cancer patients. It provides a single point of contact to help oncology healthcare providers navigate the expanded access request process.
For Healthcare Providers
For Patients & Families
Expanded Access Navigator
Reagan-Udall Foundation for the FDA
The Expanded Access Navigator is a free resource that guides patients and physicians through the expanded access process. It includes a searchable directory of pharmaceutical company policies and an electronic form submission tool.
This information is for educational purposes only and is not medical advice. Discuss all treatment options with your healthcare team.