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)
Full Report (164 pages - 648 Kb PDF file)
Continuing Education Articles
- Post-marketing Surveillance for Adverse Events After Vaccination: The National Vaccine Adverse Event Reporting
System (VAERS)
Article(PDF format) (CE
credit expired)
- Improving Patient Care by Reporting Problems with Medical Devices
Article (PDF format) (CE
credit expired)
- The Clinical Impact of Adverse Event Reporting
Article (PDF format) (CE
credit expired)
- Communication Dynamics: A Resource in Assuring Drug Quality
Article (CE credit expired)
- Clinical Therapeutics and the Recognition of Drug Induced Disease
Article (PDF format) (CE
credit expired)
Note: Use 8 1/2" x 14" paper to print this PDF document.
FDA Consumer Magazine
Food & Drug Interactions
(PDF format)
- (1998 National Consumers League Brochure)
FDA Medical Bulletins
Minimizing Medical Product Errors
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 ( PDF
format)
Annual Adverse Drug Experience Report
(A descriptive overview of the evaluable, postmarket adverse drug experience cases received by FDA each
year.)
1995 ( PDF
format)
1996