Author Affiliations: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
For over 40 years, analysis of spontaneous adverse event reporting has been the cornerstone of the drug safety surveillance system of the Food and Drug Administration (FDA). This system, which relies on observations made at the point of care, is used to identify adverse drug reactions (ADRs) that were not detected during clinical trials but emerge after a product is marketed and used in a wider population. Results of this surveillance system have been used for many regulatory actions.1
Dal Pan GJ, Temple R. Balancing Transparency and UncertaintyComment on “Potential Safety Signals and Their Significance”. Arch Intern Med. 2012;172(1):74-75. doi:10.1001/archinternmed.2011.546