Community-acquired bacterial pneumonia: developing drugs for treatment

Community-acquired 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):
Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- 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 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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (17 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918230898406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918230898406676