Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This guidance finalizes the draft guidance of the same title issued on December 15, 2022.
Abstract as published in the Federal Register.
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