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FDAnews Drug Daily Bulletin
Oct. 12, 2012 | Vol. 9 No. 201
Draft Guidance Suggests 28-Day Goal for cIAI Clinical Trials
Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance. The FDA defines clinical failure as persistence of cIAI symptoms, unplanned surgical or percutaneous drainage procedures, initiation of rescue antibacterial therapy or death.
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