Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment May 2014
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0589.