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# Guide on Mycobacterial Pulmonary Disease
- URL: https://www.fdaweb.com/guide-on-mycobacterial-pulmonary-disease/
- Published: 2023-09-01T12:00:00.000Z
- Updated: 2026-09-14T18:54:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155233

FDA has released a [final guidance](https://www.fda.gov/media/171783/download?ref=fdaweb.com) entitled “Nontuberculous Mycobacterial Pulmonary Disease Caused by *Mycobacterium avium* Complex (MAC): Developing Drugs for Treatment.” The document addresses clinical trial design issues, choice of trial population, and endpoints for the treating naïve and refractory NTM-PD caused by MAC. The agency notes that the guidance does not discuss general issues of statistical analysis or clinical trial design, which are addressed in the International Council for Harmonization guidances: *E9 Statistical Principles for Clinical Trials (September 1998)*, *E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials (May 2021)*, and *E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001)*.