Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Development Healthcare-Associated Pneumonia -- drug therapy Pneumonia, Bacterial -- drug therapy Pneumonia, Ventilator-Associated -- drug therapy United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- The purpose of this guidance is to assist sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP). 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 treatment of HABP/VABP. 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (14 pages)).
- NLM Unique ID:
- 9918230995206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918230995206676