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U.S. Department of Health and Human Services

Safety

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Where to Send Completed Form FDA 3500A MANDATORY Reporting Form

Where to Send Mandatory Post-Marketing Reporting Forms and Pre-Marketing IND Safety Reports

For Post-Marketing Reports

Drugs:

Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266

Biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps):

Center for Biologics Evaluation and Research
OBE Division of Epidemiology, (HFM-220)
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Devices:

By standard mail:

MDR Mandatory Reporting
U.S. Food and Drug Administration
Center for Devices and Radiological Health
P.O. Box 3002
Rockville, MD 20847-3002

If sent by Fedex or other courier services:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
16071 Industrial Drive, Room 258
Gaithersburg, Maryland 20877-1462


For Pre-Marketing IND Safety Reports

Adverse events involving investigational (study) drugs under Investigational New Drug (IND) applications should be reported as required in the study protocol and sent to the address and contact person listed in the study protocol. They should not be submitted to the addresses listed above unless also required (by the sponsor) under applicable postmarketing reporting regulations.

Mandatory serious adverse event [SAE] reports are to be submitted under the IND at the following addresses:

CDER INDs:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of xxxx Products
5901-B Ammendale Road
Beltsville, MD 20705-1266

CDER-only Biologic INDs:

Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biologic Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266

CBER INDs:

Office of xxxx
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N 1401 Rockville Pike
Rockville, MD 20852-1448