PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|January 9, 2014
FDA Releases Guidance on the Treatment of CABP
Author(s)Pharmaceutical Technology Editors
FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
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FDA has released
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.
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