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  5. Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
  1. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Where to Send Completed Form FDA 3500A MANDATORY Reporting Form

Where to Send Completed Form FDA 3500A MANDATORY Reporting Form

For Post-Marketing Reports

Drugs:

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):

  • 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, 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:

  • 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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