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2026-05-11 · Notice · Federal Register document 2026-09269

Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability

Health and Human Services Department, Food and Drug Administration

Official abstract: 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 This guidance finalizes the draft guidance of the same title issued on December 15, 2022.

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