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Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says

Executive Summary

FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.

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