MEDWatch Program
Even the large, well-designed Phase 3 clinical studies that are conducted by drug manufacturers cannot uncover every problem that can come to light once a product is widely used. To capture more of this critical data, especially serious adverse event data, CDER receives expedited and periodic reports of new information from the drug's manufacturer. The manufacturers are required by regulation to make such reports. In addition, to promote and facilitate voluntary reporting of serious adverse events and product problems with drugs by health care practitioners, FDA initiated a new medical products reporting program called "MEDWatch." MEDWatch has been in effect since June 1993.
MEDWatch has four goals:
Make it easier for healthcare providers to report serious events.
Make it clearer to healthcare providers what types of adverse events FDA is interested in receiving.
More widely disseminate information on the FDA's actions that have resulted from adverse event and product problem reporting.
Increase healthcare providers' understanding and awareness of drug and device-induced disease.
The MEDWatch program makes it easy for healthcare professionals to report serious adverse events to FDA. It requires a single form that may be sent via postage-prepaid mail, fax or computer modem or uses a special call in phone number to verbally report.
FDA is interested in learning of serious events that follow drug use. Serious events are generally defined as those that involve death, a life-threatening condition, hospitalization, disability, a congenital anomaly or intervention to one of these serious outcomes.
In return, FDA keeps healthcare professionals informed about new safety discoveries. To date, a quarterly insert in the FDA Medical Bulletin and a quarterly MEDWatch update capture the most current safety information on a routine basis. More acute information is relayed via the Internet, letters, roundtable telecon briefings with MEDWatch partners, etc.
To learn more about FDA's MEDWatch program, visit FDA's MEDWatch home page [Notice: This link will take you outside the CDER web site].