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Sep 08, 2008
 |  BioCentury  |  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 drugs and the adverse events identified during 1Q08 (see below). FDA cautioned that a drug's appearance on the list does not mean the agency has concluded the product has the listed risk or that a causal relationship between the drug and the listed risk was identified. The agency also emphasized it is not suggesting a drug on the list should no longer be...

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