Safety
Medical Product Safety Educational Resources
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Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. |
Safety Information Resources for Health ProfessionalsLearn about medical product safety information available from FDA. |
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Video, approximately 11 minutes Windows: 300k | 150k Choose 150k bit rate videos for slower
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"Busy healthcare professionals need the best safety information at the right time to help manage their patients' care." Dr. Janet Woodcock, FDA |
FDA MedWatch and Patient Safety |
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A self-learning tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting.
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" ... Even a few voluntary reports ... can become the signal that leads to a label change or other FDA actions to improve the safe use of a medical product." Dr. Norman Marks, FDA |
MedWatch: Safety Information and Adverse Event Reporting |
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In this expert column, Norman Marks, MD, Director of the FDA's MedWatch program, discusses the role of MedWatch in adverse event reporting and in disseminating timely and targeted safety information. From Medscape Pharmacists-Expert Column, March 11, 2009
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"[MedWatch is] a trusted source of safety information as you provide the best care for your patients." Dr. Norman Marks, FDA |
Video's from FDA Patient Safety News
"MedWatch: Reporting Adverse Events" approx 1:40
A brief overview of what to report to FDA when you suspect that a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure may be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.
Managing the Risks from Medical Product Use: Creating a Risk Management Framework
Report to the FDA Commissioner From the Task Force on Risk Management, May 1999
Older Articles
- Post-marketing Surveillance for Adverse Events After Vaccination: The National Vaccine Adverse Event Reporting System (VAERS), November 1998 (PDF format)
- Improving Patient Care by Reporting Problems with Medical Devices, September 1997 (PDF format)
- The Clinical Impact of Adverse Event Reporting, October 1996 (PDF format)
- Communication Dynamics: A Resource in Assuring Drug Quality, 1998
- Clinical Therapeutics and the Recognition of Drug Induced Disease, June 1995 (PDF format)
Use 8 1/2" x 14" paper to print this PDF document.