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Guidance on Drug Development for Bacterial Pneumonia

01/10/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment. Its purpose is to assist clinical trial sponsors and investigators in developing antibacterial drugs for treating community-acquired bacterial pneumonia. The agency is requesting comments on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. The draft guidance revises a 3/20/09 draft guidance. To download this guidance, click here. To view this notice, click here.

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