![]() ![]() For more information on how to report adverse events, see Reporting Problems to FDA. The MedWatch page includes sections on how to report an adverse event, safety information, and publications. All data contained on the MedWatch form will be entered into the AERS database. It also ensures that new safety information is rapidly communicated to the medical community thereby improving patient care. The MedWatch program is for health professionals and the public to voluntarily report serious reactions and problems with medical products, such as drugs and medical devices. 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 Health Care Professional" letter, or re-evaluating an approval decision. 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. The ultimate goal of FAERS is to improve the public health by providing the best available tools for storing and analyzing safety reports. 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. ![]() This page describes how CDER works to assure the ongoing safety and effectiveness of drug products currently marketed in the United States. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision. FDA monitors adverse events such as adverse reactions and poisonings. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to several thousand patients, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. ![]()
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