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  1. Oncology Center of Excellence

Project Facilitate

Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products

Do you need help submitting a single patient IND Expanded Access (EA)/compassionate use request for a patient with cancer? FDA’s OCE can help Locate IRB resources, find an EA contact for a drug/biotech company, and complete Form FDA 3926. 8:00 AM – 4:30 PM Eastern Time (M-F); Phone: (240) 402-0004; Email: OncProjectFacilitate@fda.hhs.gov Patients: talk to your healthcare provider to discuss whether expanded access is an appropriate option. www.fda.gov/OCE

The Oncology Center of Excellence Project Facilitate call center is a pilot program to assist oncology healthcare providers or regulatory professionals in requesting access to investigational therapies for patients with cancer.

Project Facilitate is a single point of contact where FDA oncology staff will help physicians and their healthcare team through the process to submit an Expanded Access request for an individual cancer patient.   

The FDA’s Expanded Access Program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.

Investigational drugs 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 drug 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.

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. This process can be complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests. FDA allows a vast majority of these requests to proceed, and Project Facilitate is here to guide oncology healthcare providers through the process.

Project Facilitate Contact Information

  • Healthcare providers or regulatory professionals may call Project Facilitate at (240) 402-0004 from 8 a.m. to 4:30 p.m. Eastern time, Monday through Friday. Email: OncProjectFacilitate@fda.hhs.gov.
  • Patients and families with questions can call FDA’s Division of Drug Information at 301-796-3400 or email druginfo@fda.hhs.gov.

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