Issue Date: September 5, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment : Guidance for Industry
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 This guidance finalizes the draft guidance of the same title issued on September 29, 2021.
Download the Guidance Document
