
<oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
  <dc:title>Community-acquired bacterial pneumonia : developing drugs for treatment</dc:title>
  <dc:title>Guidance for industry</dc:title>
  <dc:subject>United States. Department of Health and Human Services</dc:subject>
  <dc:subject>United States. Food and Drug Administration</dc:subject>
  <dc:subject>Community-Acquired Infections</dc:subject>
  <dc:subject>Drug Development</dc:subject>
  <dc:subject>Pneumonia, Bacterial -- drug therapy</dc:subject>
  <dc:description>The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP). Specifically, this guidance addresses the FDA’s current thinking about the overall development program and clinical trial designs for drugs to support an indication for the treatment of CABP. 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.</dc:description>
  <dc:publisher>Silver Spring, MD : Center for Drug Evaluation and Research, June 2020</dc:publisher>
  <dc:contributor>United States. Department of Health and Human Services, issuing body.</dc:contributor>
  <dc:contributor>United States. Food and Drug Administration, issuing body.</dc:contributor>
  <dc:contributor>Center for Drug Evaluation and Research (U.S.), issuing body.</dc:contributor>
  <dc:type>Technical Report</dc:type>
  <dc:format>Text</dc:format>
  <dc:format>Illustrations</dc:format>
  <dc:format>1 online resource (1 PDF file (17 pages))</dc:format>
  <dc:identifier>nlm:nlmuid-9918230898406676-pdf</dc:identifier>
  <dc:identifier>9918230898406676</dc:identifier>
  <dc:identifier>http://resource.nlm.nih.gov/9918230898406676</dc:identifier>
  <dc:language>English</dc:language>
  <dc:coverage>United States</dc:coverage>
  <dc:rights>The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0</dc:rights>
</oai_dc:dc>