FDA's Expanded Access Contact Information
Key Contact Information
1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays)
For emergency requests and 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.
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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 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) | ||
|
301-796-3400 or druginfo@fda.hhs.gov |
OND Review Division contact information: Office of New Drugs |