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> FDA Draft Guidance Suggests Primary Endpoint for Clinical Trials of Complicated Abdominal Infections
Drug Industry Daily
Oct. 1, 2012
| Vol.
11 No.
192
FDA Draft Guidance Suggests Primary Endpoint for Clinical Trials of Complicated Abdominal Infections
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resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.
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