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 In this section:

                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
          Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and PackersReporting Serious Problems to FDA Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
  
  	
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Applicable Regulations

You can search the FDA's **CFR Title 21 Database** for the latest regulations. The links below will take you directly to the relevant section.

**Drugs**

	21 CFR 310.305 -- Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
		21 CFR 312.32 -- IND Safety Reports.
		21 CFR 314.80 -- Postmarketing reporting of adverse drug experiences.**Biologics**

	21 CFR 312.32 -- IND Safety Reports.
		21 CFR 600.80 -- Postmarketing reporting of adverse experiences.
		21 CFR 1271.350 -- Human Cells, Tissues, and Cellular and Tissue-Based Product Reporting

Guidance for Industry

Guidances on Electronic Submissions
	Postmarketing Reporting of Adverse Experiences

	Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
		Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting

Referencing FDA's MedWatch Program

Where to send mandatory reporting forms

MedWatch to Manufacturer Program

FDA Adverse Events Reporting System (FAERS)

Postmarketing expedited and periodic individual case safety reports with and without attachments acceptable in electronic format without paper records (effective November 29, 2001)International Conference on Harmonization (ICH)

Efficacy
	Joint Safety/Efficacy (Multidisciplinary)
	Quality
	Safety

Federal Register Publications Related to Postmarketing Reporting

[External link to the **Federal Register Search**]

5/04/2001: **Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports; Availability - NOTICE**
	[Docket No. O1D-0185] Vol. 66, No. 87, pg. 22585 - 22586
	3/12/2001: **Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability - NOTICE**
	[Docket No. O1D-0056] Vol. 66, No. 48, pg. 14391 - 14392
	11/05/1998: **Electronic Reporting of Postmarketing Adverse Drug Reactions; Request for Comments - Advanced Notice of Proposed Rulemaking (21 CFR Parts 310, 314, and 600)**
	[Docket No. 98N-0750] Vol. 63, No. 214, pg. 59746 - 59750
	10/07/1997: **Expedited Safety Reporting Requirements for Human Drug and Biological Products - Final Rule (21 CFR Parts 20, 310, 312, 314, and 600)**
	[Docket No. 93N-0181] Vol. 62, No. 194, pg. 52237 - 52253
	06/25/1997: **Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports - FINAL RULE (21 CFR Parts 310, 314, and 600)**
	[Docket No. 96N-0108] Vol. 62, No. 122, pg. 34166 - 34168
	05/19/1997: **International Conference on Harmonisation; Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability - NOTICE**
	[Docket No. 96D-0041] Vol. 62, No. 96, pg. 27470 - 27476
	10/1/1996: **International Conference on Harmonisation; Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports; Availability - NOTICE**
	[Docket No. 96D-0236] Vol. 61, No.191, pg. 51287 - 51294
	04/03/1995: **Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules - FINAL RULE (21 CFR Part 20)**
	[Docket No. 93N-0334] Vol. 60, No. 63, pg. 16962 - 16968
	03/01/1995: **International Conference on Harmonisation; Guideline on Clinical Safety Data Management; Definitions and Standards for Expedited Reporting; Availability - NOTICE**
	[Docket No. 93D-0203] Vol. 60, No. 40, pg. 11284 - 11287
	10/27/1994: **Adverse Experience Reporting Requirements for Licensed Biological Products - FINAL RULE (21 CFR Part 600)**
	[Docket No. 93N-0072] Vol. 59, No. 207, pg. 54034 - 54044
	10/27/1994: **Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products - PROPOSED RULE (21 CFR Parts 20, 310, 312, 314, and 600)**
	[Docket No. 93N-0181] Vol. 59, No. 207, pg. 54046 - 54064
	06/03/1993: **Form for Reporting Serious Adverse Events and Product Problems with Human Drug and Biological Products and Devices; Availability - NOTICE**
	[Docket No. 93N-0072] Vol. 58, No. 105, pg. 31596 - 31614

Resources For You

Form FDA 3500A - Mandatory Reporting
	Instructions for Completing Form FDA3500A

                                                                                  Content current as of:
      11/05/2019
              
              
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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