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FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
FDA has released Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment, Draft Guidance to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP). The guidance addresses development program and clinical trial designs for drugs to support an indication for the treatment of CABP and is intended to serve as a focus for continued comments and discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.
This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidance for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.
This guidance revises a 2009 guidance, Pneumonia: Developing Drugs for Treatment.