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Editor's Correspondence
May 14, 2012

Potential Safety Signals and Their Significance

Author Affiliations

Author Affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland.

Arch Intern Med. 2012;172(9):747-748. doi:10.1001/archinternmed.2012.833

As Powers and Cook1 and Dal Pan and Temple2 have stated, biweekly screening of disproportionality within the Adverse Event Reporting System (AERS) is a valuable tool for identifying potential safety signals. However, it is only 1 component of routine surveillance at the US Food and Drug Administration (FDA). In accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA performs formal safety reviews at specified time points. Twelve months after the licensure of pediatric drugs and biological products, FDA physicians review the relevant data, summarize their findings, and present the results to an independent advisory committee, who will assess the reviews and make recommendations for action.3 Postmarketing evaluations are also performed 18 months after approval of a drug or biological product or use of the product by 10 000 individuals (including both adults and children), whichever occurs later. The evaluations are performed to determine whether there are any new safety concerns that were not previously identified during product development. Safety evaluation summaries are posted on the FDA's website.4

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