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GUIDANCE DOCUMENT

Pulmonary Tuberculosis: Developing Drugs for Treatment November 2013

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 20 treatment of pulmonary tuberculosis. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of active pulmonary tuberculosis. This draft guidance is intended to serve as a focus for continued discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.3

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.