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Articles and Other Publications

FDA Report

"Managing the Risks from Medical Product Use: Creating a Risk Management Framework"
May 10, 1999 FDA Report
Executive Summary (147 Kb PDF file) Adobe Acrobat [pdf] file
Full Report (164 pages - 648 Kb PDF file) Adobe Acrobat [pdf] file


  • Post-marketing Surveillance for Adverse Events After Vaccination: The National Vaccine Adverse Event Reporting System (VAERS)
    Article(Adobe Acrobat [pdf] filePDF format)
  • Improving Patient Care by Reporting Problems with Medical Devices
    Article (Adobe Acrobat [pdf] filePDF format)
  • The Clinical Impact of Adverse Event Reporting
    Article (Adobe Acrobat [pdf] filePDF format)
  • Communication Dynamics: A Resource in Assuring Drug Quality
  • Clinical Therapeutics and the Recognition of Drug Induced Disease
    Article (Adobe Acrobat [pdf] filePDF format)
    Note: Use 8 1/2" x 14" paper to print this PDF document.

FDA Consumer Magazine

Food & Drug Interactions

(Adobe Acrobat [pdf] filePDF format) - (1998 National Consumers League Brochure)

FDA Medical Bulletins

Minimizing Medical Product Errors

Executive Summary of January 8, 1998 Workshop

FDA User Facility Reporting Bulletins
(A quarterly bulletin to assist hospitals, nursing homes, and other device user facilities)

Other Publications

FDA Quarterly Data Extract from the Adverse Event Reporting System (AERS)
go to the National Technical Information Service (NTIS) Search page at: http://www.ntis.gov/search/index.asp?loc=3-0-0
enter "AERS" as the search term.

"National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)"
Taxonomy of Medication Errors (Adobe Acrobat [pdf] file PDF format)

Annual Adverse Drug Experience Report
(A descriptive overview of the evaluable, postmarket adverse drug experience cases received by FDA each year.)
1995 (Adobe Acrobat [pdf] file PDF format)

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