FDA Logo links to FDA home page
U.S. Food and Drug Administration
  HHS Logo links to Department of Health and Human Services website
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program


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

Mandatory MedWatch Reporting Form and Instructions

  • Visit the MedWatch Download Forms page to get copies of the Mandatory Reporting FDA Form 3500A in PDF format.

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


Guidance for Industry


Guidance for FDA Field Staff

MedWatch to Manufacturer Program


Electronic Submission Postmarketing Safety Reports

  • 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 of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

    The initiatives that directly affect postmarketing surveillance are:
    • MedDRA Term Selection: Points to Consider - an ICH-Endorsed Guide for MedDRA Users  Adobe Acrobat [pdf] format [External Link]
    • M1 MedDRA (Medical Dictionary for Regulatory Activities)
    • M2 ESTRI (Electronic Standards for the Transfer of Regulatory Information)
    • E2A Adobe Acrobat [pdf] format (Clinical Safety Data Management)
    • E2B Adobe Acrobat [pdf] format (Guidance On Data Elements For Transmission of Individual Case Safety Reports)
    • E2BM Adobe Acrobat [pdf] format (Guidance on Data Elements for Transmission of Individual Case Safety Reports)
    • E2C Adobe Acrobat [pdf] format PSUR (Periodic Safety Update Report)

Federal Register Publications Related to Postmarketing Reporting

[External link to the Federal Register.]
Most documents listed here may be downloaded in TEXT and/or Adobe Acrobat [pdf] formatPDF format.

  • 5/04/01: (Adobe Acrobat [pdf] formatPDF format)
      Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports; Availability - NOTICE
      [Docket No. O1D-0185] Vol. 66, No. 87, pg. 22585 - 22586

  • 3/12/01: (Adobe Acrobat [pdf] formatPDF format)
      Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability - NOTICE
      [Docket No. O1D-0056] Vol. 66, No. 48, pg. 14391 - 14392

  • 11/05/98: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 10/07/97: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 06/25/97: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 05/19/97: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 10/1/96: (TEXT format)
      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

  • 04/03/95: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 03/01/95: (TEXT format or Adobe Acrobat [pdf] formatPDF format)
      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

  • 10/27/94: (TEXT format)
      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

  • 10/27/94: (TEXT format)
      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

  • 06/03/93:
      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

 

horizonal rule