Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community Home
          About FDA
          FDA Organization
          Oncology Center of Excellence
          Project FacilitateOncology Center of Excellence Project Facilitate
  
  					Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products
	
    Share
    Post
    Linkedin

    Email
    PrintImage
              Project Facilitate Main Image 2021Oncology 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.


background image

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 WeekendsProject 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 druginfo@fda.hhs.gov.

**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

                                                                                  Content current as of:
      11/24/2021Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop