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

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

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