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6:17 PM
Sep 28, 2012
 |  BC Extra  |  Politics & Policy

FDA issues guidance on antibiotics for cIAI

FDA issued draft guidance on the development of drugs to treat complicated intra-abdominal infection (cIAI). The agency recommended the use of active-controlled, non-inferiority Phase III trials for patients for whom an effective therapy is already available. In patients who have limited treatment options, such as those who are intolerant to marketed drugs...

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