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GUIDANCE DOCUMENT

Community-Acquired Bacterial Pneumonia — Developing Drugs for Treatment January 2014

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2009-D-0136
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of CABP. This draft guidance is intended to serve as a focus for continued comments and discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.


Submit Comments

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:

Dockets Management
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-2009-D-0136.