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                Expanded Access

Expanded Access

                        Expanded Access | Information for Patients
          Expanded Access | Information for Physicians
          Expanded Access | Information for Industry
          Expanded Access | How to Submit a Request (Forms)
          Expanded Access | Keywords, Definitions, and Resources
          Expanded Access (Compassionate Use) Submission Data
          FDA's Expanded Access Contact Information Home
          News & Events
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          Expanded Access
          FDA's Expanded Access Contact InformationExpanded Access FDA's Expanded Access Contact Information
  
  	
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Key Contact Information

1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays)

For **specific questions**during normal business hours:

**Investigational drugs:** 301-796-3400 or druginfo@fda.hhs.gov [CDER's Division of Drug Information], or contact the appropriate review division, if known

	**Oncology drugs:** 240-402-0004 or ONCProjectFacilitate@fda.hhs.gov
	**Investigational medical devices:** 301-796-7100 or DICE@fda.hhs.gov [CDRH's Division of Industry and Consumer Education]
	**Investigational biologics:** 240-402-8020 or 800-835-4709 or industry.biologics@fda.hhs.gov [CBER's Office of Communication, Outreach and Development]For **general questions**, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or patientaffairs@fda.hhs.gov.

2. 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.





Mailing Addresses for Expanded Access Applications

Drug Products
			Biologic Products
			Medical Devices***Individual Patient IND Requests and Follow-up Reports submitted by a licensed physician using FDA Form 3926***
			***Individual Patient IND Requests and Follow-up Reports submitted by a licensed physician using FDA Form 3926***
			***Individual Patient Expanded Access Requests and Follow-up Reports (including Emergency Use Reports)***Food and Drug Administration
			Center for Drug Evaluation and Research
			Central Document Room
			ATTN: [appropriate Review Division]
			“EXPANDED ACCESS SUBMISSION”
			5901-B Ammendale Rd.
			Beltsville, Md. 20705-1266
			Food and Drug Administration
			Center for Biologics Evaluation and Research
			Document Control Center
			10903 New Hampshire Avenue
			Bldg. 71, Rm. G112
			Silver Spring, MD 20993-0002
			Food and Drug Administration
			Center for Devices and Radiological Health
			Document Mail Center
			10903 New Hampshire Avenue
			Bldg. 66, Rm. G609
			Silver Spring, MD 20993-0002
			If an IDE exists for the device, include the IDE number in the request.Learn more about medical device expanded access here.

***For other submission options, contact FDA using the information below. Please call or e-mail before faxing documents.***

FDA Centers and Review Divisions

Centers / Review Divisions
			Telephone Number / email
			Fax Number
			call review division before sending fax**Center for Biologic and Evaluation Research (CBER)
			Office of Communication, Outreach and Development**
			240-402-8020 or 800-835-4709 orindustry.biologics@fda.hhs.gov**Center for Devices and Radiological Health (CDRH)
			Division of Industry and Consumer Education**
			301-796-7100 orDICE@fda.hhs.gov**Center for Drug Evaluation and Research (CDER)**Division of Drug Information (DDI)
			301-796-3400 ordruginfo@fda.hhs.gov
			OND Review Division contact information: Office of New Drugs

Resources For You

Visit the Expanded Access (Compassionate Use) main page

                                                                                  Content current as of:
      12/21/2022Expanded Access

          
                        Information for Patients
          Information for Physicians
          Information for Industry
          How to Submit a Request (Forms)
          Keywords, Definitions, and Resources
          Submission Data
          Contact Information
 
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