Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices | FDA

Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices | FDA

Statement from Center for Drug Evaluation and Research Director Janet Woodcock. M.D., on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

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 ...

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