2023-19060: Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium Avium Complex: Developing Drugs for Treatment; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment." This guidance assists sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC). This guidance finalizes the draft guidance of the same title issued on September 29, 2021.
The agency’s own summary, as published.
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