News & Events

FDA's Expanded Access Contact Information

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
  • 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 ProductsBiologic ProductsMedical Devices
Individual Patient IND Requests and Follow-up Reports submitted by a licensed physician using FDA Form 3926Individual 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 DivisionsTelephone Number / emailFax 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 or
industry.biologics@fda.hhs.gov
 
Center for Devices and Radiological Health (CDRH)
Division of Industry and Consumer Education
301-796-7100 or
DICE@fda.hhs.gov
 
 Center for Drug Evaluation and Research (CDER)  
  • Division of Drug Information (DDI)
301-796-3400 or
druginfo@fda.hhs.gov
 
301-796-1300301-796-9887
301-796-2330301-796-9845
  • Oncology Products 2 (Gastrointestinal, Lung/Head&Neck, Neuro-oncology/Rare Cancers/Solid Tumor Pediatric Malignancies, Melanoma/Sarcoma)
301-796-2320301-796-9849 
301-796-7550301-796-9845
301-796-2130301-796-9897
  • Medical Imaging Products
301-796-2050301-796-9848
301-796-2120301-796-9904
301-796-2280301-796-9723
301-796-2290301-796-9712
301-796-2300301-796-9723
301-796-2110301-796-9895
301-796-2240301-796-9838
301-796-2250301-796-9840
301-796-2260301-796-9842

 

Page Last Updated: 11/08/2018
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