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                Reporting Serious Problems to FDA

Reporting Serious Problems to FDA

                        What is a Serious Adverse Event?
          Product Problems
          Reporte  problemas serios a la FDA
          ¿Qué es una reacción adversa grave?
          Problemas con los productos Home
          Safety
          MedWatch: The FDA Safety Information and Adverse Event Reporting Program
          Reporting Serious Problems to FDA
          Where to Send Completed Form FDA 3500A MANDATORY Reporting FormReporting Serious Problems to FDA Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
  
  	
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    PrintFor 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 20993-0002Note: All postmarketing AE reports for CDER-regulated biologics cannot be submitted on a 3500A, they must be submitted electronically.

**Cosmetics**:

Please submit the completed MedWatch 3500A form along with information to support the report, such as scans of labels and images of the serious adverse event, to FDA via:

Email (preferred method for faster processing and reviewing):
	CosmeticAERS@fda.hhs.govMail:
	FDA CDER Mail Center
		Attn: Cosmetics MedWatch reports
		White Oak Campus, Building 22, G0207
		10903 New Hampshire Ave.
		Silver Spring, MD 20993**Devices**:

By standard mail:

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

                                                                                  Content current as of:
      12/29/2023
              
              
Regulated Product(s)
		 DrugsReporting Serious Problems to FDA

          
                        What is a Serious Adverse Event?
          Product Problems
          Reporte  problemas serios a la FDA
          ¿Qué es una reacción adversa grave?
          Problemas con los productos
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