What Students Need To Know About Post Marketing Pharmacovigilance Practice at FDA

FDA monitors adverse events such as adverse reactions and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision. The FDA Adverse Event Reporting System (FAERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of FAERS is to improve the public health by providing the best available tools for storing and analyzing safety reports. The reports in FAERS are evaluated by a multidisciplinary staff safety evaluators, epidemiologists and other scientists in the Center for Drug Evaluation and Research’s (CDER) Office of Surveillance and Epidemiology to detect safety signals and to monitor drug safety. As a result, the FDA may take regulatory actions to improve product safety and protect the public health, such as updating a product’s labeling information, sending out a “Dear Heal