Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two million adverse event reports submitted every year to the FDA Adverse Event Reporting System (FAERS) through the MedWatch Program and to the Vaccine Adverse Event Reporting System (VAERS) by patients, family members, and health care providers, as well as adverse event reports submitted by regulated industry. Staff in our Office of Surveillance and Epidemiology and CBER’s Office of Biostatistics and Epidemiology use this information to identify safety concerns and recommend actions to improve product safety and protect the public.
(adsbygoogle = window.adsbygoogle || []).push({});


