Docket Number:
FDA-2021-D-0544
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).

Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding clinical trial design issues, choice of study population, and endpoints for the treatment of naïve and refractory NTM-PD caused by MAC. The design of clinical trials of new drugs for the treatment of NTM-PD was discussed during an FDA public workshop.

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All written comments should be identified with this document's docket number: FDA-2021-D-0544.