RegulatoryGuideline · final
Pulmonary Tuberculosis: Developing Drugs for Treatment
🇺🇸 FDA · Mon 11 May 2026
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 This guidance finalizes the draft guidance of the same title issued on December 15, 2022.
Official guideline text: FDA ↗
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