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GUIDANCE DOCUMENT

Pulmonary Tuberculosis: Developing Drugs for Treatment December 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-1319
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pulmonary Tuberculosis: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This draft guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB. This draft guidance revises and replaces the draft guidance for industry of the same name published on November 6, 2013.

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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-2013-D-1319.

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