Safety

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:

Starting June 10, 2015, FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) Electronic Submissions for information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing individual case safety reports (ICSRs) with and without attachments.

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

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

Note: All postmarketing AE reports for CDER-regulated biologics cannot be submitted on a 3500A, they must be submitted electronically.

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:

Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
8400 Corporate Drive, Suite 500
Landover, MD 20785

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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:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

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Page Last Updated: 05/21/2018
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