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GUIDANCE DOCUMENT

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment January 2014

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2009-D-0136
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

[Updated: 6/24/2020]

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment This guidance does not discuss the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), respectively.

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All written comments should be identified with this document's docket number: FDA-2009-D-0136.

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