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GUIDANCE DOCUMENT

Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment May 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0589
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

[updated: 6/24/2020]

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.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0589.

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