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GUIDANCE DOCUMENT

Pulmonary Tuberculosis: Developing Drugs for Treatment May 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
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 final guidance for industry titled “Pulmonary Tuberculosis: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This guidance finalizes the draft guidance of the same title issued on December 15, 2022.

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