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Editor's Correspondence
May 14, 2012

Potential Safety Signals and Their Significance—Reply

Author Affiliations

Author Affiliations: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

Arch Intern Med. 2012;172(9):747-748. doi:10.1001/archinternmed.2012.1035

In reply

My colleague, Dr Woo, correctly points out that the US Food and Drug Administration (FDA) uses a multimodal approach to monitoring the safety of marketed medicines and biological products. Our methods include review of spontaneous adverse event reports, active surveillance systems, drug use analyses, epidemiological studies, clinical trials, and review of medication error reports. As needed, these data are linked to clinical pharmacological and toxicological data. Dr Woo also correctly indicates that the FDA now has the authority to require Risk Evaluation and Mitigation Strategies (REMS) when relevant statutory requirements are met. One component of a REMS is an assessment of the program at specified intervals after the REMS has been approved. These assessments are also an important component of postmarket safety review.