Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products
Oncology Center of Excellence Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program.
FDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.
Investigational medical products have not yet been approved by the FDA and the FDA has not found these products to be safe and effective for their specific use. The investigational medical products may, or may not, be effective in the treatment of the condition, and use of the product may cause serious side effects that were not expected.
The request process can be complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests. To make a request, a member of the patient’s healthcare team will approach the pharmaceutical company to ask for its agreement that it will provide the medical product. The company has the right to approve or disapprove the physician’s request.
The FDA Expanded Access Program allows a vast majority of these requests to proceed, and Project Facilitate is here to guide oncology healthcare providers through the process.
Health Care Providers or Health Regulatory Professionals
For questions, please call Project Facilitate at (240)402-0004 (M-F, 8:00am to 4:30pm, ET) or email Expanded Access Requests to: OncProjectFacilitate@fda.hhs.gov
To learn more about Project Facilitate please enjoy this short video (less than 90 seconds)
Project Facilitate Contact Information
Healthcare Providers or Regulatory Professionals
Project Facilitate: (240) 402-0004, Monday – Friday • 8:00am to 4:30pm ET
After-hours Emergency Requests for all medical products (drugs, biologics & medical devices): call FDA's Emergency Call Center: 866-300-4374 Monday – Friday after 4:30pm ET, and Weekends
Project Facilitate Expanded Access Request Submission Information
Please email your expanded access requests to Project Facilitate: OncProjectFacilitate@fda.hhs.gov.
Patients and Families
For questions, please call FDA’s Division of Drug Information at 301-796-3400 or email email@example.com.
Listen to a patient with cancer describe how Project Facilitate helped her receive an investigational therapy.
For more information
- Three-minute video on Project Facilitate
- FDA Expanded Access Program
- Reagan-Udall Foundation Expanded Access Navigator
- Reagan-Udall Foundation Expanded Access eRequest (Physicians)
- Expanded Access Video Series
- Enhancing the Single Patient IND Process for Oncology Health Care Providers Public Workshop
- Press Announcement: FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer