FDA introduces new MedWatch reporting and learning tools

June 5, 2013

As it celebrates the 20th anniversary of its MedWatch program, FDA has launched two new tools designed to make it easier for consumers and healthcare professionals to report product information to the agency

As it celebrates the 20th anniversary of its MedWatch program, FDA has launched two new tools designed to make it easier for consumers and healthcare professionals to report product information to the agency.

MedWatch allows healthcare professionals and consumers to submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product.

The agency uses that information to make necessary changes to medication labels, to issue product recalls, warning, and safety messages, and to determine how patients receiving products should be monitored.

FDA has introduced a new form that’s more consumer-friendly. It was developed with input from groups such as AARP, Consumers Union, and the National Women's Health Network. 

The agency has also introduced a new web-based learning tool, MedWatchLearn, which instructs students, healthcare professionals and consumers on how to correctly complete a report. It also provides examples of properly prepared reports.