What is MedWatch?
FDA has the responsibility for assuring the safety and efficacy
of all regulated marketed medical products.
MedWatch, The FDA Safety Information and Adverse
Event Reporting Program, serves both healthcare professionals
and the medical product-using public. We provide important
and timely clinical information about safety issues involving
medical products, including prescription and over-the-counter
drugs, biologics, medical and radiation-emitting devices,
and special nutritional products (e.g., medical foods, dietary
supplements and infant formulas).
Medical product safety alerts, recalls, withdrawals,
and important labeling changes that may affect the health
of all Americans are quickly disseminated to the medical community
and the general public via this web site and the MedWatch
E-list. Select Safety Information
to see reports, safety notifications, and labeling changes
posted to the website since 1996.
MedWatch allows healthcare
professionals and consumers
to report serious problems that they suspect are associated
with the drugs and medical devices they prescribe, dispense,
or use. Reporting can be done on
line, by phone, or by submitting the MedWatch 3500 form
by mail or fax. Select How to Report
for more details.