Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
MedWatch Tips & Tools for Health Professionals
FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. FDA Drug Info Rounds pharmacists discuss how FDA’s MedWatch program makes it easy to get important safety information directly from you to us. Run time 3 min 14 sec
MedWatch for Nurses: Clinically Important Reporting and Safety Resources for Practice
FDA's MedWatch Program is a valuable resource for nurses in any practice setting, providing important information on all medical products as well as for reporting problems with them. Run time 2 min.
Safety Information Resources for Physicians
Busy doctors need a quick method of finding up-to-date and science-based new safety information on the human medical products that they use, prescribe or administer in patient care. MedWatch delivers free Safety Alerts to doctors, either online or delivered to the doctor at the point-of-care via email or text message to their computer or smartphone. Run time 5 min.
Reporting Product Problems to FDA: Video For Consumers
Reports of problems submitted to FDA by consumers are an important part of the agency’s strategy for identifying risks with products after they’ve reached the market. These reports help FDA protect the health and safety of all Americans—and can ultimately save lives. MedWatch Medical Director Norman Marks explains how the public can submit reports and how the agency uses this information. Run time 3 min.
Reporting Product Problems to FDA: Video For Healthcare Professionals
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 human medical product. Run time 3 min 50 seconds.
Bad Reactions to Cosmetics? Tell FDA!
From styling our hair to showering before bed, Americans love cosmetics. Most are safe, but some cause problems, and that's when the Food and Drug Administration gets involved. Run time 1 min 34 sec.
A national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies.
Safety Information Resources for Health Professionals
Learn about medical product safety information available from FDA.
Video, approximately 11 minutes
Choose 150k bit rate videos for slower internet connections.
"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
A self-learning tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting.
- Video, approximately 24 minutes.
- Powerpoint presentation [25 slides]
- Self-administered quiz with answers
" ... 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
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.
Medscape Pharmacists-Expert Column, March 11, 2009
"[MedWatch is] a trusted source of safety information as you provide the best care for your patients."
Dr. Norman Marks, FDA
In this editorial, FDA Medical Officers Norman Marks and Karen Weiss discuss the risk communication tools used by the FDA to provide science- based, credible, and timely information that make a physician's job easier and patients safer.
American Family Physician, February 1, 2010, Volume 81, Number 3
"Well-placed information can assist a busy physician in locating new drug safety information at the point of care."
Dr. Norman Marks, FDA
Dr. Karen Weiss, FDA
A joint presentation by FDA and the American Nurses Association provides information on safe disposal of unused or expired treatments, medications, and devices used in the home setting.
"As healthcare has shifted from the hospital setting to the home, so have nurses who often provide the care. This webinar educates nurses and their patients on how to handle these risks."
Christine Merenda, RN, FDA
Introducing MedWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, JAMA, June 2, 1993, Vol 269, No 21. David Kessler, MD.
Original article announcing the implementation and rationale for the MedWatch program.
Report to the FDA Commissioner From the Task Force on Risk Management, May 1999
- 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.