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7:00 AM GMT, Sep 8, 2008
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Regulation

Refinement wanted

Refinement wanted

As mandated by the FDA Amendments Act of 2007, FDA last week released its first quarterly report on potential signals of risk for marketed drugs. Under FDAAA, the agency must report new safety information or potential signals of a serious risk identified by the adverse event reporting system (AERS) each quarter. The report included a table listing more than 20

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This article and the information contained in BioCentury's publications and services are solely for your own personal, non-transferable licensed use and cannot be shared with any other individuals. For information about adding subscribers to your account or obtaining article reprints, please contact support@biocentury.com.