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

 
• By Martin Berman-Gorvine

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.

While backing the use of ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) for pneumonic plague in twin unanimous votes held a day apart, close questioning from members of FDA's Anti-Infective Drugs Advisory Committee signaled that they would hold studies conducted under the Animal Rule to at least as high a standard as human clinical trials in the future.

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