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U.S. Department of Health and Human Services

Safety

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Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers

 

Information on mandatory reporting:

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.

 

Guidance for Industry

 

Referencing FDA's MedWatch Program

 

Preparing a Facsimile of FDA Form 3500A

 

Contact information for questions about mandatory reporting

 

Where to send mandatory reporting forms

 

MedWatch to Manufacturer Program


Adverse Events Reporting System (AERS) Electronic Submissions

  • 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)

 

Guidance for FDA Field Staff

 

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