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FDA drug safety committee

This article was originally published in The Tan Sheet

Executive Summary

The first in a series of meetings held by the Drug Safety & Risk Management Advisory Committee will take place May 18 and 19 at the Holiday Inn in Silver Spring, Md., 8:30 am - 5 pm, according to an April 14 Federal Register notice. Panelists will consider the advantages and disadvantages of FDA's current risk assessment program and safety detection of marketed drugs, including "review and analysis" of spontaneous adverse events reports, drug use data, administrative data, epidemiologic and observational studies, clinical trials and active surveillance systems...

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