Posted by Michael Wonder on 07 Nov 2019
Statement on the agency’s efforts to protect patients through post-market drug safety surveillance practices
6 November 2019 - Public health and safety is the highest priority at the U.S. FDA.
We maintain a robust practice of post-market 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 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.
