Pulmonary tuberculosis drug development guidance finalized
- Indication
- pulmonary tuberculosis
FDA finalizes guidance for sponsors developing antibacterial drugs to treat pulmonary tuberculosis.
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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 This guidance finalizes the draft guidance of the same title issued on December 15, 2022.
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Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work