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 patient with cancer.
Watch a short video (less than 90 seconds) to learn about Project Facilitate.
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.
- Three-minute video on Project Facilitate
- FDA Drug Topics: FDA Oncology Center of Excellence’s Project Facilitate: An Overview of the Oncology Expanded Access Program – October 29, 2019
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.
- After 4:30 p.m. ET weekdays and all day on weekends: For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency Call Center at 866-300-4374
- Healthcare providers may submit oncology expanded access requests to Project Facilitate via email at: OncProjectFacilitate@fda.hhs.gov.
- Patients and families with questions can call FDA’s Division of Drug Information at 301-796-3400 or email email@example.com.
For more information
- 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